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FDA 510(k)

ACTIVHEAL SCAR MANAGEMENT DRESSING

K-Number: K010245 · 2001-04-25

ApplicantAdvanced Medical Solutions, Ltd.
Decision Date2001-04-25
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACTIVHEAL SCAR MANAGEMENT DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions, Ltd.. It received FDA 510(k) clearance on 2001-04-25 under 510(k) number K010245. 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 ACTIVHEAL SCAR MANAGEMENT DRESSING?

ACTIVHEAL SCAR MANAGEMENT DRESSING is a medical device that received FDA 510(k) clearance on 2001-04-25. The listed applicant is Advanced Medical Solutions, Ltd.. The 510(k) number is K010245.

When did ACTIVHEAL SCAR MANAGEMENT DRESSING receive FDA 510(k) clearance?

ACTIVHEAL SCAR MANAGEMENT DRESSING received FDA 510(k) clearance on 2001-04-25, under 510(k) number K010245.

Who is the listed applicant for ACTIVHEAL SCAR MANAGEMENT DRESSING?

The FDA 510(k) record lists Advanced Medical Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIVHEAL SCAR MANAGEMENT DRESSING?

The FDA product code for ACTIVHEAL SCAR MANAGEMENT DRESSING is MDA.

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Other records listing Advanced Medical Solutions, Ltd. as applicant

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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

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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