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FDA 510(k)

SILON SILICONE GEL SHEET

K-Number: K932214 · 1994-01-06

ApplicantBio Med Sciences, Inc.
Decision Date1994-01-06
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILON SILICONE GEL SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Bio Med Sciences, Inc.. It received FDA 510(k) clearance on 1994-01-06 under 510(k) number K932214. 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 SILON SILICONE GEL SHEET?

SILON SILICONE GEL SHEET is a medical device that received FDA 510(k) clearance on 1994-01-06. The listed applicant is Bio Med Sciences, Inc.. The 510(k) number is K932214.

When did SILON SILICONE GEL SHEET receive FDA 510(k) clearance?

SILON SILICONE GEL SHEET received FDA 510(k) clearance on 1994-01-06, under 510(k) number K932214.

Who is the listed applicant for SILON SILICONE GEL SHEET?

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

What is the FDA product code for SILON SILICONE GEL SHEET?

The FDA product code for SILON SILICONE GEL SHEET is MDA.

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Other records listing Bio Med Sciences, 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.

K023136OLEEVA FABRICK002109OLEEVA FOAMK990042SILON DUAL-DRESSK982036SILON SCAR STRIPSK952546SILON SILICONE TEXTILE COMPOSITEK946362SILON SILICONE FOAM SHEETING

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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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