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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K905514
Device Name AUTOGENESIS(TM) AUTOMATOR
Applicant
Advanced Biosearch Assn.
3880 Blackhawk Rd.
Danville,  CA  94506
Applicant Contact RODGER J RICHEAL
Correspondent
Advanced Biosearch Assn.
3880 Blackhawk Rd.
Danville,  CA  94506
Correspondent Contact RODGER J RICHEAL
Regulation Number888.3030
Classification Product Code
KTT  
Date Received12/07/1990
Decision Date 04/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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