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FDA 510(k) Application Details - K130557
Device Classification Name
Cuff, Nerve
More FDA Info for this Device
510(K) Number
K130557
Device Name
Cuff, Nerve
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
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Contact
STEPHEN H BEIER
Other 510(k) Applications for this Contact
Regulation Number
882.5275
More FDA Info for this Regulation Number
Classification Product Code
JXI
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More FDA Info for this Product Code
Date Received
03/04/2013
Decision Date
04/24/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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