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FDA 510(k) Application Details - K132250
Device Classification Name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
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510(K) Number
K132250
Device Name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Applicant
INTEGRA LIFE SCIENCES CORPORATION
311 ENTERPRISE DRIVE
PLAINSBORO, NJ 08536 US
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FREDERIC TESTA
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Regulation Number
888.3800
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Classification Product Code
JWJ
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Date Received
07/19/2013
Decision Date
03/24/2014
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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