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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 K021008
Device Name ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
Applicant
Advanced Orthopaedic Solutions, Inc.
333 W. 6th St., Suite 202
San Pedro,  CA  90731
Applicant Contact PAUL DONER
Correspondent
Advanced Orthopaedic Solutions, Inc.
333 W. 6th St., Suite 202
San Pedro,  CA  90731
Correspondent Contact PAUL DONER
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/28/2002
Decision Date 06/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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