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FDA 510(k)

SIL-K

K-Number: K914701 · 1992-01-31

ApplicantDegania Silicone , Ltd.
Decision Date1992-01-31
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIL-K is the device name listed in this FDA 510(k) record. The listed applicant is Degania Silicone , Ltd.. It received FDA 510(k) clearance on 1992-01-31 under 510(k) number K914701. 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 SIL-K?

SIL-K is a medical device that received FDA 510(k) clearance on 1992-01-31. The listed applicant is Degania Silicone , Ltd.. The 510(k) number is K914701.

When did SIL-K receive FDA 510(k) clearance?

SIL-K received FDA 510(k) clearance on 1992-01-31, under 510(k) number K914701.

Who is the listed applicant for SIL-K?

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

What is the FDA product code for SIL-K?

The FDA product code for SIL-K is MDA.

Other records listing Degania Silicone , Ltd. as applicant

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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

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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