FDA 510(k) Application Details - K031651

Device Classification Name Filler, Bone Void, Calcium Compound

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510(K) Number K031651
Device Name Filler, Bone Void, Calcium Compound
Applicant CURASAN AG
LINDIGSTRASSE 4
KLEINOSTHEIM 63801 DE
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Contact ROLF KAUFMANN
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Regulation Number 888.3045

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Classification Product Code MQV
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Date Received 05/28/2003
Decision Date 08/13/2003
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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