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FDA 510(k)

CARAPASTE ORAL WOUND DRESSING

K-Number: K082856 · 2008-10-15

ApplicantMcgrath Pharmaceuticals, Inc.
Decision Date2008-10-15
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

CARAPASTE ORAL WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Mcgrath Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2008-10-15 under 510(k) number K082856. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARAPASTE ORAL WOUND DRESSING?

CARAPASTE ORAL WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2008-10-15. The listed applicant is Mcgrath Pharmaceuticals, Inc.. The 510(k) number is K082856.

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

CARAPASTE ORAL WOUND DRESSING received FDA 510(k) clearance on 2008-10-15, under 510(k) number K082856.

Who is the listed applicant for CARAPASTE ORAL WOUND DRESSING?

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

What is the FDA product code for CARAPASTE ORAL WOUND DRESSING?

The FDA product code for CARAPASTE ORAL WOUND DRESSING is OLR.

Related Clinical Trials

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Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

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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