FDA 510(k) Application Details - K021336

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K021336
Device Name Filler, Bone Void, Calcium Compound
Applicant NovaBone Products, LLC
ONE PROGRESS BLVD.
SUITE 33
ALACHUA, FL 32615 US
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Contact DAVID M GAISSER
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 04/26/2002
Decision Date 07/25/2002
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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