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FDA 510(k)

UNITED SKIN BARRIERS

K-Number: K844046 · 1984-11-29

ApplicantHowmedica Corp.
Decision Date1984-11-29
Product CodeEXB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNITED SKIN BARRIERS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1984-11-29 under 510(k) number K844046. The device is classified under product code EXB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITED SKIN BARRIERS?

UNITED SKIN BARRIERS is a medical device that received FDA 510(k) clearance on 1984-11-29. The listed applicant is Howmedica Corp.. The 510(k) number is K844046.

When did UNITED SKIN BARRIERS receive FDA 510(k) clearance?

UNITED SKIN BARRIERS received FDA 510(k) clearance on 1984-11-29, under 510(k) number K844046.

Who is the listed applicant for UNITED SKIN BARRIERS?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNITED SKIN BARRIERS?

The FDA product code for UNITED SKIN BARRIERS is EXB.

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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.

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