FDA 510(k) Application Details - K041620

Device Classification Name Cuff, Nerve

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510(K) Number K041620
Device Name Cuff, Nerve
Applicant INTEGRA LIFESCIENCES CORP.
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536 US
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Contact DIANA M BORDON
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Regulation Number 882.5275

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Classification Product Code JXI
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Date Received 06/16/2004
Decision Date 07/16/2004
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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