FDA 510(k)

OSMOCYTE WOUND MANAGER SHEET DRESSING

K-Number: K965143 · 1997-05-22

Decision Date1997-05-22

Product CodeMGQ

DecisionSubstantially Equivalent

Device Summary

OSMOCYTE WOUND MANAGER SHEET 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 1997-05-22 under 510(k) number K965143. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSMOCYTE WOUND MANAGER SHEET DRESSING?

OSMOCYTE WOUND MANAGER SHEET DRESSING is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Procyte Corp.. The 510(k) number is K965143.

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

OSMOCYTE WOUND MANAGER SHEET DRESSING received FDA 510(k) clearance on 1997-05-22, under 510(k) number K965143.

Who is the listed applicant for OSMOCYTE WOUND MANAGER SHEET 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 WOUND MANAGER SHEET DRESSING?

The FDA product code for OSMOCYTE WOUND MANAGER SHEET DRESSING is MGQ.

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Other records listing Procyte Corp. 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.