FDA 510(k) Application Details - K040276

Device Classification Name Prosthesis, Hip, Cement Restrictor

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510(K) Number K040276
Device Name Prosthesis, Hip, Cement Restrictor
Applicant QUANTUM ORTHOPEDICS
11662 CORTE GUERA
SAN DIEGO, CA 92128 US
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Contact JASON BLAIN
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Regulation Number 878.3300

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Classification Product Code JDK
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Date Received 02/05/2004
Decision Date 04/30/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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