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FDA 510(k)

CICA-CARE SILICONE GEL SHEET

K-Number: K935803 · 1994-02-03

ApplicantSmith & Nephew United, Inc.
Decision Date1994-02-03
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CICA-CARE SILICONE GEL SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K935803. 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 CICA-CARE SILICONE GEL SHEET?

CICA-CARE SILICONE GEL SHEET is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K935803.

When did CICA-CARE SILICONE GEL SHEET receive FDA 510(k) clearance?

CICA-CARE SILICONE GEL SHEET received FDA 510(k) clearance on 1994-02-03, under 510(k) number K935803.

Who is the listed applicant for CICA-CARE SILICONE GEL SHEET?

The FDA 510(k) record lists Smith & Nephew United, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CICA-CARE SILICONE GEL SHEET?

The FDA product code for CICA-CARE SILICONE GEL SHEET is MDA.

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Other records listing Smith & Nephew United, Inc. as applicant

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Related Devices (Code: MDA)

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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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