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FDA 510(k) Application Details - K142339
Device Classification Name
Wax,Bone
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510(K) Number
K142339
Device Name
Wax,Bone
Applicant
ORTHOCON, LLC
1 Bridge Street -Suite 121
Irvington, NY 10533 US
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Contact
Howard L Schrayer
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Regulation Number
000.0000
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Classification Product Code
MTJ
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More FDA Info for this Product Code
Date Received
08/21/2014
Decision Date
09/26/2014
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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