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FDA 510(k)

SILGEL TOPICAL GEL SHEET

K-Number: K974172 · 1998-03-30

ApplicantNagor , Ltd.
Decision Date1998-03-30
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILGEL TOPICAL GEL SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Nagor , Ltd.. It received FDA 510(k) clearance on 1998-03-30 under 510(k) number K974172. 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 SILGEL TOPICAL GEL SHEET?

SILGEL TOPICAL GEL SHEET is a medical device that received FDA 510(k) clearance on 1998-03-30. The listed applicant is Nagor , Ltd.. The 510(k) number is K974172.

When did SILGEL TOPICAL GEL SHEET receive FDA 510(k) clearance?

SILGEL TOPICAL GEL SHEET received FDA 510(k) clearance on 1998-03-30, under 510(k) number K974172.

Who is the listed applicant for SILGEL TOPICAL GEL SHEET?

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

What is the FDA product code for SILGEL TOPICAL GEL SHEET?

The FDA product code for SILGEL TOPICAL GEL SHEET is MDA.

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Other records listing Nagor , Ltd. 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.

K984029SILGEL STC-S

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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