FDA 510(k)

SCAR CARE

K-Number: K971009 · 1997-07-29

Decision Date1997-07-29

Product CodeMDA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SCAR CARE is the device name listed in this FDA 510(k) record. The listed applicant is Target Health, Inc.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K971009. 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 CARE?

SCAR CARE is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Target Health, Inc.. The 510(k) number is K971009.

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

SCAR CARE received FDA 510(k) clearance on 1997-07-29, under 510(k) number K971009.

Who is the listed applicant for SCAR CARE?

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

What is the FDA product code for SCAR CARE?

The FDA product code for SCAR CARE is MDA.

Other records listing Target Health, 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.

K971549VMT SYSTEM K973271SKAR-KARE

Related Devices (Code: MDA)

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.