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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K911594
Device Name ORALCAM
Applicant
Charmac Group, Inc.
7382 Bolsa Ave.
Westminster,  CA  92683
Applicant Contact WILLIAM CHARNESKI
Correspondent
Charmac Group, Inc.
7382 Bolsa Ave.
Westminster,  CA  92683
Correspondent Contact WILLIAM CHARNESKI
Regulation Number872.6640
Classification Product Code
EIA  
Date Received04/09/1991
Decision Date 07/03/1991
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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