FDA 510(k) Application Details - K071583

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

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510(K) Number K071583
Device Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
Applicant IMPLANTS INTERNATIONAL, LTD
71 JAY AVE.TEESIDE INDSTRL.EST
THORNABY-ON TEES
UNITED KINGDOM T517-9LZ GB
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Contact MOHAN EMMANUEL
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Regulation Number 888.3353

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Classification Product Code MEH
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Date Received 06/08/2007
Decision Date 07/25/2007
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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