FDA 510(k) Application Details - K052329

Device Classification Name Stimulator, Neuromuscular, External Functional

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510(K) Number K052329
Device Name Stimulator, Neuromuscular, External Functional
Applicant INNOVATIVE NEUROTRONICS INC.
TWO BETHESDA METRO CENTER
SUTE 1200
BETHESDA, MD 20814 US
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Contact FAYYAZ MEMON
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Regulation Number 882.5810

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Classification Product Code GZI
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Date Received 08/25/2005
Decision Date 09/21/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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