FDA 510(k) Application Details - K073068

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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510(K) Number K073068
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant ACCELERATED INNOVATION, LLC
1033 US HIGHWAY 46 EAST
SUITE A204
CLIFTON, NJ 07013 US
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Contact MICHAEL KVITNITSKY
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 10/30/2007
Decision Date 01/10/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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