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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K913949
Device Name TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS
Applicant
Applied Osteo Systems, Inc.
1515 Oakland Blvd., Suite 110
Walnut Creek,  CA  94596
Applicant Contact MICHAEL PENTOPOULOS
Correspondent
Applied Osteo Systems, Inc.
1515 Oakland Blvd., Suite 110
Walnut Creek,  CA  94596
Correspondent Contact MICHAEL PENTOPOULOS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/09/1991
Decision Date 01/17/1992
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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