FDA 510(k) Application Details - K032730

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

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510(K) Number K032730
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
3 HASADNAOT
HERZELIA 46728 IL
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Contact HILA WACHSLER-AVRAHAMI
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Regulation Number 888.3350

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Classification Product Code JDI
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Date Received 09/03/2003
Decision Date 03/26/2004
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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