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FDA 510(k) Application Details - K040216
Device Classification Name
Filler, Bone Void, Calcium Compound
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510(K) Number
K040216
Device Name
Filler, Bone Void, Calcium Compound
Applicant
CURASAN AG
109 SHORE DRIVE
GARNER, NC 27529 US
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Contact
ERIC WIECHERT
Other 510(k) Applications for this Contact
Regulation Number
888.3045
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Classification Product Code
MQV
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More FDA Info for this Product Code
Date Received
01/30/2004
Decision Date
03/26/2004
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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