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FDA 510(k)

OSMOCYTE ISLAND WOUND DRESSING

K-Number: K972150 · 1997-12-10

ApplicantProcyte Corp.
Decision Date1997-12-10
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

OSMOCYTE ISLAND 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 K972150. 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 ISLAND WOUND DRESSING?

OSMOCYTE ISLAND 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 K972150.

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

OSMOCYTE ISLAND WOUND DRESSING received FDA 510(k) clearance on 1997-12-10, under 510(k) number K972150.

Who is the listed applicant for OSMOCYTE ISLAND 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 ISLAND WOUND DRESSING?

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

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Other records listing Procyte Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971612OSMO/PCA PILLOW WOUND DRESSINGK972329OSMOCYTE RA WOUND DRESSINGK970153LAMIN-2 HYDRATING GELK965143OSMOCYTE WOUND MANAGER SHEET DRESSINGK965005IAMIN IMPREGNATED GAUZE DRESSINGK964468IAMIN WET DRESSING (COPPER-SALINE)

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Related Devices (Code: KMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, Inc.

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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