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FDA 510(k)

TRI BLOCK POLUMER GEL SHEETING

K-Number: K942695 · 1994-11-10

ApplicantSilipos, Inc.
Decision Date1994-11-10
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRI BLOCK POLUMER GEL SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Silipos, Inc.. It received FDA 510(k) clearance on 1994-11-10 under 510(k) number K942695. 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 TRI BLOCK POLUMER GEL SHEETING?

TRI BLOCK POLUMER GEL SHEETING is a medical device that received FDA 510(k) clearance on 1994-11-10. The listed applicant is Silipos, Inc.. The 510(k) number is K942695.

When did TRI BLOCK POLUMER GEL SHEETING receive FDA 510(k) clearance?

TRI BLOCK POLUMER GEL SHEETING received FDA 510(k) clearance on 1994-11-10, under 510(k) number K942695.

Who is the listed applicant for TRI BLOCK POLUMER GEL SHEETING?

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 TRI BLOCK POLUMER GEL SHEETING?

The FDA product code for TRI BLOCK POLUMER GEL SHEETING is MDA.

Related Clinical Trials

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.

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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.

K955664STERILIZED TRI BLOCK POLYMER GEL SHEETK944240SOFT SOCKK932048SILICONE 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

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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