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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
510(k) Number K813224
Device Name CERAVITAL CERAMIC EAR CANAL WALL PROSTH
Applicant
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Correspondent
Xomed, Inc.
1318 Lonedell Rd.
Arnold,  MO  63010
Regulation Number878.3500
Classification Product Code
ESF  
Date Received11/09/1981
Decision Date 04/21/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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