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FDA 510(k)

DEGANIA SILICONE SIL-K

K-Number: K971482 · 1997-06-24

ApplicantDegania Silicone , Ltd.
Decision Date1997-06-24
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEGANIA SILICONE 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 1997-06-24 under 510(k) number K971482. 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 DEGANIA SILICONE SIL-K?

DEGANIA SILICONE SIL-K is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Degania Silicone , Ltd.. The 510(k) number is K971482.

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

DEGANIA SILICONE SIL-K received FDA 510(k) clearance on 1997-06-24, under 510(k) number K971482.

Who is the listed applicant for DEGANIA SILICONE 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 DEGANIA SILICONE SIL-K?

The FDA product code for DEGANIA SILICONE SIL-K is MDA.

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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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