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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 K961901
Device Name BONE & MARROW COLLECTION SYSTEM
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  
Subsequent Product Code
HWK  
Date Received05/16/1996
Decision Date 08/06/1996
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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