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FDA 510(k)

DEGANIA SILICONE INDENTI LOOPS

K-Number: K964547 · 1997-01-08

ApplicantDegania Silicone , Ltd.
Decision Date1997-01-08
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEGANIA SILICONE INDENTI LOOPS 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 1997-01-08 under 510(k) number K964547. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEGANIA SILICONE INDENTI LOOPS?

DEGANIA SILICONE INDENTI LOOPS is a medical device that received FDA 510(k) clearance on 1997-01-08. The listed applicant is Degania Silicone , Ltd.. The 510(k) number is K964547.

When did DEGANIA SILICONE INDENTI LOOPS receive FDA 510(k) clearance?

DEGANIA SILICONE INDENTI LOOPS received FDA 510(k) clearance on 1997-01-08, under 510(k) number K964547.

Who is the listed applicant for DEGANIA SILICONE INDENTI LOOPS?

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 INDENTI LOOPS?

The FDA product code for DEGANIA SILICONE INDENTI LOOPS is DXC.

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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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