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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 K974622
Device Name DENTAL D
Applicant
Micro Dental Laboratories
6665 Amador Plaza Rd., #200
Dublin,  CA  94568
Applicant Contact NICOLAS E AZAR
Correspondent
Micro Dental Laboratories
6665 Amador Plaza Rd., #200
Dublin,  CA  94568
Correspondent Contact NICOLAS E AZAR
Regulation Number872.3285
Classification Product Code
EHP  
Date Received12/11/1997
Decision Date 02/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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