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FDA 510(k)

A4-XLR8 FOAM DRESSING

K-Number: K092992 · 2010-06-29

ApplicantGenadyne Biotechnologies, Inc.
Decision Date2010-06-29
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

A4-XLR8 FOAM DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2010-06-29 under 510(k) number K092992. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A4-XLR8 FOAM DRESSING?

A4-XLR8 FOAM DRESSING is a medical device that received FDA 510(k) clearance on 2010-06-29. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K092992.

When did A4-XLR8 FOAM DRESSING receive FDA 510(k) clearance?

A4-XLR8 FOAM DRESSING received FDA 510(k) clearance on 2010-06-29, under 510(k) number K092992.

Who is the listed applicant for A4-XLR8 FOAM DRESSING?

The FDA 510(k) record lists Genadyne Biotechnologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A4-XLR8 FOAM DRESSING?

The FDA product code for A4-XLR8 FOAM DRESSING is OMP.

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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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