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FDA 510(k)

STERILIZED TRI BLOCK POLYMER GEL SHEET

K-Number: K955664 · 1996-02-28

ApplicantSilipos, Inc.
Decision Date1996-02-28
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILIZED TRI BLOCK POLYMER GEL SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Silipos, Inc.. It received FDA 510(k) clearance on 1996-02-28 under 510(k) number K955664. 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 STERILIZED TRI BLOCK POLYMER GEL SHEET?

STERILIZED TRI BLOCK POLYMER GEL SHEET is a medical device that received FDA 510(k) clearance on 1996-02-28. The listed applicant is Silipos, Inc.. The 510(k) number is K955664.

When did STERILIZED TRI BLOCK POLYMER GEL SHEET receive FDA 510(k) clearance?

STERILIZED TRI BLOCK POLYMER GEL SHEET received FDA 510(k) clearance on 1996-02-28, under 510(k) number K955664.

Who is the listed applicant for STERILIZED TRI BLOCK POLYMER GEL SHEET?

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

What is the FDA product code for STERILIZED TRI BLOCK POLYMER GEL SHEET?

The FDA product code for STERILIZED TRI BLOCK POLYMER GEL SHEET is MDA.

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Other records listing Silipos, 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.

K944240SOFT SOCKK942695TRI BLOCK POLUMER GEL SHEETINGK932048SILICONE GEL SHEETING

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

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