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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Teeth, Porcelain
510(k) Number K852145
Device Name CAPA PRE-FORMED PORCELAIN CROWN
Applicant
Capa Industries
P.O. Box 961
Vienna,  VA  22180
Applicant Contact LOUIS T GNECCO
Correspondent
Capa Industries
P.O. Box 961
Vienna,  VA  22180
Correspondent Contact LOUIS T GNECCO
Regulation Number872.3920
Classification Product Code
ELL  
Date Received05/16/1985
Decision Date 07/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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