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FDA 510(k)

NOVAGEL SILICONE GEL SHEETING

K-Number: K941125 · 1994-05-31

ApplicantBrennen Medical, Inc.
Decision Date1994-05-31
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOVAGEL SILICONE GEL SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Brennen Medical, Inc.. It received FDA 510(k) clearance on 1994-05-31 under 510(k) number K941125. 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 NOVAGEL SILICONE GEL SHEETING?

NOVAGEL SILICONE GEL SHEETING is a medical device that received FDA 510(k) clearance on 1994-05-31. The listed applicant is Brennen Medical, Inc.. The 510(k) number is K941125.

When did NOVAGEL SILICONE GEL SHEETING receive FDA 510(k) clearance?

NOVAGEL SILICONE GEL SHEETING received FDA 510(k) clearance on 1994-05-31, under 510(k) number K941125.

Who is the listed applicant for NOVAGEL SILICONE GEL SHEETING?

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

What is the FDA product code for NOVAGEL SILICONE GEL SHEETING?

The FDA product code for NOVAGEL SILICONE GEL SHEETING is MDA.

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Other records listing Brennen Medical, 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.

K050086BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSINGK030460MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXK021835BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEXK002077GLUCANPRO CREAMK002078BETA GLUCAN GEL (MACROPRO GEL)K000519GLUCANPRO

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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