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FDA 510(k)

MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE

K-Number: K974354 · 1998-03-05

ApplicantSca Molnlycke
Decision Date1998-03-05
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE is the device name listed in this FDA 510(k) record. The listed applicant is Sca Molnlycke. It received FDA 510(k) clearance on 1998-03-05 under 510(k) number K974354. 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 MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE?

MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE is a medical device that received FDA 510(k) clearance on 1998-03-05. The listed applicant is Sca Molnlycke. The 510(k) number is K974354.

When did MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE receive FDA 510(k) clearance?

MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE received FDA 510(k) clearance on 1998-03-05, under 510(k) number K974354.

Who is the listed applicant for MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE?

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

What is the FDA product code for MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE?

The FDA product code for MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE 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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