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FDA 510(k) Application Details - K043260
Device Classification Name
Wax,Bone
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510(K) Number
K043260
Device Name
Wax,Bone
Applicant
ORTHOCON, LLC
167 STONE HILL ROAD
COLTS NECK, NY 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
11/24/2004
Decision Date
08/12/2005
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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