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FDA 510(k)

SILGEL TOPICAL GEL SHEET

K-Number: K960254 · 1996-04-02

ApplicantRofil Medical USA, Inc.
Decision Date1996-04-02
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 Rofil Medical USA, Inc.. It received FDA 510(k) clearance on 1996-04-02 under 510(k) number K960254. 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 1996-04-02. The listed applicant is Rofil Medical USA, Inc.. The 510(k) number is K960254.

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

SILGEL TOPICAL GEL SHEET received FDA 510(k) clearance on 1996-04-02, under 510(k) number K960254.

Who is the listed applicant for SILGEL TOPICAL GEL SHEET?

The FDA 510(k) record lists Rofil Medical USA, Inc. 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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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.

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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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