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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment
510(k) Number K905451
Device Name SYSTEM TEN, MODEL 100 SURGERY SYST/ORTHOPAEDIC USE
Applicant
Advanced Osseous Technologies
C/O Charles L. Rose & Co., Inc
1963 Rock St., Suite #17
Mountain View,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
Advanced Osseous Technologies
C/O Charles L. Rose & Co., Inc
1963 Rock St., Suite #17
Mountain View,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number888.4580
Classification Product Code
JDX  
Date Received12/05/1990
Decision Date 03/05/1991
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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