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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clasp, Preformed
510(k) Number K955946
Device Name ACETAL DENTAL/PREFORMED CLASP
Applicant
Pressing DI Monticelli Rag. Stefano
233 Via Emilia Romagna
Cattilica,  IT 47033
Applicant Contact STEFANO MONTICELLI
Correspondent
Pressing DI Monticelli Rag. Stefano
233 Via Emilia Romagna
Cattilica,  IT 47033
Correspondent Contact STEFANO MONTICELLI
Regulation Number872.3285
Classification Product Code
EHP  
Date Received10/27/1995
Decision Date 12/11/1995
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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