FDA 510(k)

OSMOCYTE RA WOUND DRESSING

K-Number: K972329 · 1997-12-10

Decision Date1997-12-10

Product CodeKMF

Advisory CommitteeHO

DecisionSubstantially Equivalent for Some Indications

Device Summary

OSMOCYTE RA WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Procyte Corp.. It received FDA 510(k) clearance on 1997-12-10 under 510(k) number K972329. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OSMOCYTE RA WOUND DRESSING?

OSMOCYTE RA WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1997-12-10. The listed applicant is Procyte Corp.. The 510(k) number is K972329.

When did OSMOCYTE RA WOUND DRESSING receive FDA 510(k) clearance?

OSMOCYTE RA WOUND DRESSING received FDA 510(k) clearance on 1997-12-10, under 510(k) number K972329.

Who is the listed applicant for OSMOCYTE RA WOUND DRESSING?

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

What is the FDA product code for OSMOCYTE RA WOUND DRESSING?

The FDA product code for OSMOCYTE RA WOUND DRESSING is KMF.

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Other records listing Procyte Corp. as applicant

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Related Devices (Code: KMF)

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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.