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FDA 510(k)

SKAR-KARE

K-Number: K973271 · 1997-11-19

ApplicantTarget Health, Inc.
Decision Date1997-11-19
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKAR-KARE 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 1997-11-19 under 510(k) number K973271. 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 SKAR-KARE?

SKAR-KARE is a medical device that received FDA 510(k) clearance on 1997-11-19. The listed applicant is Target Health, Inc.. The 510(k) number is K973271.

When did SKAR-KARE receive FDA 510(k) clearance?

SKAR-KARE received FDA 510(k) clearance on 1997-11-19, under 510(k) number K973271.

Who is the listed applicant for SKAR-KARE?

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 SKAR-KARE?

The FDA product code for SKAR-KARE 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 SYSTEMK971009SCAR CARE

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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