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FDA 510(k)

KMC NEWSKIN

K-Number: K974143 · 1998-03-27

ApplicantKmc Intl. Co.
Decision Date1998-03-27
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KMC NEWSKIN is the device name listed in this FDA 510(k) record. The listed applicant is Kmc Intl. Co.. It received FDA 510(k) clearance on 1998-03-27 under 510(k) number K974143. 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 KMC NEWSKIN?

KMC NEWSKIN is a medical device that received FDA 510(k) clearance on 1998-03-27. The listed applicant is Kmc Intl. Co.. The 510(k) number is K974143.

When did KMC NEWSKIN receive FDA 510(k) clearance?

KMC NEWSKIN received FDA 510(k) clearance on 1998-03-27, under 510(k) number K974143.

Who is the listed applicant for KMC NEWSKIN?

The FDA 510(k) record lists Kmc Intl. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KMC NEWSKIN?

The FDA product code for KMC NEWSKIN 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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