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FDA 510(k) Application Details - K113627
Device Classification Name
Wax,Bone
More FDA Info for this Device
510(K) Number
K113627
Device Name
Wax,Bone
Applicant
ORTHOCON
1 BRIDGE STREET
SUITE 121
IRVINGTON, NY 10533 US
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Contact
ROSEMARY HARRY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MTJ
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More FDA Info for this Product Code
Date Received
12/08/2011
Decision Date
02/17/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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