FDA 510(k) Application Details - K002098

Device Classification Name Cuff, Nerve

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510(K) Number K002098
Device Name Cuff, Nerve
Applicant SALUMEDICA, L.L.C.
112 KROG ST.
SUITE 4
ATLANTA, GA 30307 US
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Contact DAVID N KU
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Regulation Number 882.5275

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Classification Product Code JXI
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Date Received 07/11/2000
Decision Date 11/24/2000
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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