FDA 510(k)

AMERICAN PHARMASEAL WOUND DRESSING

K-Number: K871770 · 1987-06-26

Decision Date1987-06-26

Product CodeFRO

DecisionSubstantially Equivalent for Some Indications

Device Summary

AMERICAN PHARMASEAL WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1987-06-26 under 510(k) number K871770. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AMERICAN PHARMASEAL WOUND DRESSING?

AMERICAN PHARMASEAL WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1987-06-26. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K871770.

When did AMERICAN PHARMASEAL WOUND DRESSING receive FDA 510(k) clearance?

AMERICAN PHARMASEAL WOUND DRESSING received FDA 510(k) clearance on 1987-06-26, under 510(k) number K871770.

Who is the listed applicant for AMERICAN PHARMASEAL WOUND DRESSING?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERICAN PHARMASEAL WOUND DRESSING?

The FDA product code for AMERICAN PHARMASEAL WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.