FDA 510(k) Application Details - K040199

Device Classification Name Cerclage, Fixation

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510(K) Number K040199
Device Name Cerclage, Fixation
Applicant OSSEUS, LLC
3131 PRINCETON PIKE
BLDG. 5, SUITE 200
LAWRENCEVILLE, NJ 08648 US
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Contact SHAWN T HUXEL
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Regulation Number 888.3010

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Classification Product Code JDQ
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Date Received 01/29/2004
Decision Date 02/20/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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