FDA 510(k) Application Details - K062459

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K062459
Device Name Filler, Bone Void, Calcium Compound
Applicant NANOTHERAPEUTICS
12337 NW 9TH LANE
NEWBERRY, FL 32669 US
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Contact PAULA WILKERSON
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 08/23/2006
Decision Date 02/26/2007
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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