FDA 510(k)

SCAR HEAL

K-Number: K971468 · 1997-06-10

Decision Date1997-06-10

Product CodeMDA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SCAR HEAL is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Systems, Inc.. It received FDA 510(k) clearance on 1997-06-10 under 510(k) number K971468. 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 SCAR HEAL?

SCAR HEAL is a medical device that received FDA 510(k) clearance on 1997-06-10. The listed applicant is Specialty Systems, Inc.. The 510(k) number is K971468.

When did SCAR HEAL receive FDA 510(k) clearance?

SCAR HEAL received FDA 510(k) clearance on 1997-06-10, under 510(k) number K971468.

Who is the listed applicant for SCAR HEAL?

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

What is the FDA product code for SCAR HEAL?

The FDA product code for SCAR HEAL is MDA.

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, LLC K053481KELO-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.