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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K080647
Device Name ACCIN BIPOLAR HEAD SYSTEM
Applicant
Accelerated Innovation, LLC
1033 Us Highway 46e
Suite A204
Clifton,  NJ  07013
Applicant Contact MICHAEL KVITMITSKY
Correspondent
Accelerated Innovation, LLC
1033 Us Highway 46e
Suite A204
Clifton,  NJ  07013
Correspondent Contact MICHAEL KVITMITSKY
Regulation Number888.3390
Classification Product Code
KWY  
Date Received03/07/2008
Decision Date 07/08/2008
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
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