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FDA 510(k) Application Details - K141502
Device Classification Name
Wax,Bone
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510(K) Number
K141502
Device Name
Wax,Bone
Applicant
ORTHOCON, INC.
1 Bridge St Ste 121
Irvington, NY 10533 US
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Contact
Howard 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
06/06/2014
Decision Date
10/03/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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