FDA 510(k) Application Details - K051603

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K051603
Device Name Filler, Bone Void, Calcium Compound
Applicant STRYKER LEIBINGER MICRO IMPLANTS
750 TRADE CENTRE WAY
PORTAGE, MI 49002 US
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Contact WADE T RUTKOSKIE
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 06/15/2005
Decision Date 12/30/2005
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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