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FDA 510(k)

BLAINE SCARCARE PATCH

K-Number: K001608 · 2000-07-25

ApplicantBlaine Labs, Inc.
Decision Date2000-07-25
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLAINE SCARCARE PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Blaine Labs, Inc.. It received FDA 510(k) clearance on 2000-07-25 under 510(k) number K001608. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLAINE SCARCARE PATCH?

BLAINE SCARCARE PATCH is a medical device that received FDA 510(k) clearance on 2000-07-25. The listed applicant is Blaine Labs, Inc.. The 510(k) number is K001608.

When did BLAINE SCARCARE PATCH receive FDA 510(k) clearance?

BLAINE SCARCARE PATCH received FDA 510(k) clearance on 2000-07-25, under 510(k) number K001608.

Who is the listed applicant for BLAINE SCARCARE PATCH?

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

What is the FDA product code for BLAINE SCARCARE PATCH?

The FDA product code for BLAINE SCARCARE PATCH is MDA.

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Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, 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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