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FDA 510(k)

SKIN 2 FORTE SILICONE SHEETING

K-Number: K990651 · 1999-08-13

ApplicantUnited Hospital Technologies, Inc.
Decision Date1999-08-13
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKIN 2 FORTE SILICONE SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is United Hospital Technologies, Inc.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K990651. 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 SKIN 2 FORTE SILICONE SHEETING?

SKIN 2 FORTE SILICONE SHEETING is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is United Hospital Technologies, Inc.. The 510(k) number is K990651.

When did SKIN 2 FORTE SILICONE SHEETING receive FDA 510(k) clearance?

SKIN 2 FORTE SILICONE SHEETING received FDA 510(k) clearance on 1999-08-13, under 510(k) number K990651.

Who is the listed applicant for SKIN 2 FORTE SILICONE SHEETING?

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

What is the FDA product code for SKIN 2 FORTE SILICONE SHEETING?

The FDA product code for SKIN 2 FORTE SILICONE SHEETING is MDA.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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