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IState)51()Nme Name of Manufacturer (Town, - Food and Drug

IState)51()Nme Name of Manufacturer (Town, - Food and Drug 2025

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The document is a 510(k) summary for the Penumbra Embolectomy Aspiration System, submitted by Penumbra Inc. It outlines the device's intended use for removing fresh, soft emboli and thrombi from peripheral arterial vessels, its classification as a Class II embolectomy catheter, and its substantial equivalence to predicate devices. The summary includes details on the device's description, non-clinical data supporting safety and effectiveness, biocompatibility testing results, bench-top testing outcomes, and an animal study confirming no significant vascular response. The document concludes with FDA correspondence affirming the device's marketability under general controls.

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Click ‘Get Form’ to open it in the editor.
Begin by entering the Sponsor/Applicant Name and Address. This section requires the full name of the manufacturer along with their complete address.
Fill in the Sponsor Contact Information. Include the name, phone number, fax number, and email of the contact person responsible for regulatory affairs.
Provide the Date of Preparation of the 510(k) Summary. Ensure this date is accurate as it reflects when the summary was compiled.
Enter the Device Trade or Proprietary Name. This should match what is officially registered for your device.
Complete the Common/Usual Name field with the standard name used in practice for your device.
Fill out Device Classification details including Regulatory Class, Classification Panel, Classification Name, Regulation Number, and Product Code as applicable.
Incorporate any Predicate Devices information if relevant to establish substantial equivalence.

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

Where is the Food and Drug Administration located in the United States?

The FDA headquarters is on the White Oak campus in Silver Spring, Maryland, in Montgomery County.

Is FDA in the United States?

The United States Food and Drug Administration (FDA) was first created to enforce the Pure Food and Drug Act of 1906.

Where is the US food and drug administration?

The FDA headquarters is on the White Oak campus in Silver Spring, Maryland, in Montgomery County. The FDA has additional offices across the U.S. Visitors to White Oak can use public transportation (Metro train and bus, commuter trains and buses) or taxi and ridesharing services. Limited visitor parking is available.

What is the name of the food and drug agency?

Food and Drug Administration (FDA)

How many locations does the FDA have?

The FDAs headquarters is located in the White Oak area of Silver Spring, Maryland. The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Islands, and Puerto Rico.

What is the 510 of the Federal Food Drug and Cosmetic Act?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

Where is the Usfda located?

FDA headquarters facilities are located in Montgomery and Prince Georges Counties in Maryland. Many FDA employees are consolidated at the White Oak Campus located in Silver Spring, MD. Remaining headquarters employees are housed in numerous additional buildings located across the Washington, D.C. area.

How to find manufacturer on drug label?

In most prescriptions, you will find the NDC number on the label. In the example below, the NDC number is in the lower right-hand corner. The first five digits of an NDC number identify the manufacturer.

IState)51()Nme Name of Manufacturer (Town, - Food and Drug 2025

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