FDA 510(k) Application Details - K053468

Device Classification Name Stimulator, Neuromuscular, External Functional

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510(K) Number K053468
Device Name Stimulator, Neuromuscular, External Functional
Applicant NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
555 13TH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact JONATHAN S KAHN
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Regulation Number 882.5810

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Classification Product Code GZI
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Date Received 12/13/2005
Decision Date 07/07/2006
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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