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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Ac-Powered
510(k) Number K964073
Device Name BME BONE DRILL BITS
Applicant
Biomedical Ent., Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Applicant Contact W. CASEY FOX
Correspondent
Biomedical Ent., Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Correspondent Contact W. CASEY FOX
Regulation Number878.4820
Classification Product Code
GEY  
Date Received10/11/1996
Decision Date 11/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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