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FDA 510(k)

COUDE/ OR TIEMANN

K-Number: K103371 · 2011-03-11

ApplicantDegania Silicone , Ltd.
Decision Date2011-03-11
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COUDE/ OR TIEMANN 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 2011-03-11 under 510(k) number K103371. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COUDE/ OR TIEMANN?

COUDE/ OR TIEMANN is a medical device that received FDA 510(k) clearance on 2011-03-11. The listed applicant is Degania Silicone , Ltd.. The 510(k) number is K103371.

When did COUDE/ OR TIEMANN receive FDA 510(k) clearance?

COUDE/ OR TIEMANN received FDA 510(k) clearance on 2011-03-11, under 510(k) number K103371.

Who is the listed applicant for COUDE/ OR TIEMANN?

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 COUDE/ OR TIEMANN?

The FDA product code for COUDE/ OR TIEMANN is EZL.

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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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