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FDA 510(k)

MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT

K-Number: K962013 · 1996-08-22

ApplicantMentor Corp.
Decision Date1996-08-22
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1996-08-22 under 510(k) number K962013. 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 MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT?

MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT is a medical device that received FDA 510(k) clearance on 1996-08-22. The listed applicant is Mentor Corp.. The 510(k) number is K962013.

When did MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT receive FDA 510(k) clearance?

MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT received FDA 510(k) clearance on 1996-08-22, under 510(k) number K962013.

Who is the listed applicant for MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT?

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

What is the FDA product code for MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT?

The FDA product code for MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT is MDA.

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Other records listing Mentor Corp. 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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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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