FDA 510(k) Application Details - K974514

Device Classification Name Stimulator, Neuromuscular, External Functional

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510(K) Number K974514
Device Name Stimulator, Neuromuscular, External Functional
Applicant NEUROMOTION, INC.
401 11044-82 AVENUE
EDMONTON, ALBERTA T6G 0T2 CA
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Contact BRAIN ZERB
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Regulation Number 882.5810

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Classification Product Code GZI
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Date Received 12/01/1997
Decision Date 02/06/1998
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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