FDA 510(k) Application Details - K060917

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K060917
Device Name Filler, Bone Void, Calcium Compound
Applicant KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON, PA 19341 US
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Contact JENNIFER J BOSLEY
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 04/04/2006
Decision Date 09/22/2006
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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