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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Bone, Surgical
510(k) Number K914035
Device Name MINI-MILL
Applicant
Biomedical Composites, Ltd.
5464 Carpinteria Ave. #219
Carpinteria,  CA  93013
Applicant Contact RICHARD MULLARKY
Correspondent
Biomedical Composites, Ltd.
5464 Carpinteria Ave. #219
Carpinteria,  CA  93013
Correspondent Contact RICHARD MULLARKY
Regulation Number872.4565
Classification Product Code
EMI  
Date Received09/10/1991
Decision Date 03/02/1992
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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