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FDA 510(k)

NEODYNE DRESSING

K-Number: K112131 · 2011-09-29

ApplicantNeodyne Biosciences, Inc.
Decision Date2011-09-29
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEODYNE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Neodyne Biosciences, Inc.. It received FDA 510(k) clearance on 2011-09-29 under 510(k) number K112131. 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 NEODYNE DRESSING?

NEODYNE DRESSING is a medical device that received FDA 510(k) clearance on 2011-09-29. The listed applicant is Neodyne Biosciences, Inc.. The 510(k) number is K112131.

When did NEODYNE DRESSING receive FDA 510(k) clearance?

NEODYNE DRESSING received FDA 510(k) clearance on 2011-09-29, under 510(k) number K112131.

Who is the listed applicant for NEODYNE DRESSING?

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

What is the FDA product code for NEODYNE DRESSING?

The FDA product code for NEODYNE DRESSING 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.

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.K024057CURAD SCAR THERAPYBeiersdorf, 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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