CERAVITAL CERAMIC OSSICULAR REPL. PROS.

Replacement, Ossicular Prosthesis, Total

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Ceravital Ceramic Ossicular Repl. Pros..

Pre-market Notification Details

Device IDK810707
510k NumberK810707
Device Name:CERAVITAL CERAMIC OSSICULAR REPL. PROS.
ClassificationReplacement, Ossicular Prosthesis, Total
Applicant XOMED, INC. 1318 LONEDELL RD. Arnold,  MO  63010
Product CodeETA  
CFR Regulation Number874.3495 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-16
Decision Date1981-06-16

NIH GUDID Devices

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