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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K926465
Device Name FEMORAL INTRAMEDULLARY RODS
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 Number888.3030
Classification Product Code
JDS  
Date Received12/24/1992
Decision Date 08/25/1993
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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