FDA 510(k) Application Details - K072398

Device Classification Name Stimulator, Neuromuscular, External Functional

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510(K) Number K072398
Device Name Stimulator, Neuromuscular, External Functional
Applicant RESTORATIVE THERAPIES INC.
907 SOUTH LAKEWOOD AVE.
BALTIMORE, MD 21224 US
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Contact ANDREW BARRISKILL
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Regulation Number 882.5810

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Classification Product Code GZI
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Date Received 08/27/2007
Decision Date 11/21/2007
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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