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FDA 510(k)

GELSPRAY WOUND DRESSING

K-Number: K073663 · 2008-01-30

ApplicantBiocure, Inc.
Decision Date2008-01-30
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GELSPRAY WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Biocure, Inc.. It received FDA 510(k) clearance on 2008-01-30 under 510(k) number K073663. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELSPRAY WOUND DRESSING?

GELSPRAY WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2008-01-30. The listed applicant is Biocure, Inc.. The 510(k) number is K073663.

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

GELSPRAY WOUND DRESSING received FDA 510(k) clearance on 2008-01-30, under 510(k) number K073663.

Who is the listed applicant for GELSPRAY WOUND DRESSING?

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

What is the FDA product code for GELSPRAY WOUND DRESSING?

The FDA product code for GELSPRAY WOUND DRESSING is KMF.

Related Clinical Trials

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.

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Other records listing Biocure, Inc. 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.

K023089GELSPHERES EMBOLIC AGENT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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