FDA 510(k) Application Details - K131923

Device Classification Name Stimulator, Neuromuscular, External Functional

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510(K) Number K131923
Device Name Stimulator, Neuromuscular, External Functional
Applicant TECHLINK INTERNATIONAL
PO BOX 694125
MIAMI, FL 33269 US
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Contact TARA CONRAD
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Regulation Number 882.5810

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Classification Product Code GZI
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Date Received 06/26/2013
Decision Date 07/03/2014
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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