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FDA 510(k) Application Details - K062353
Device Classification Name
Filler, Bone Void, Calcium Compound
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510(K) Number
K062353
Device Name
Filler, Bone Void, Calcium Compound
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
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Contact
DIANA M BORDON
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
08/11/2006
Decision Date
12/20/2006
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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