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FDA 510(k) Application Details - K071113
Device Classification Name
Stimulator, Neuromuscular, External Functional
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510(K) Number
K071113
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
Other 510(k) Applications for this Contact
Regulation Number
882.5810
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Classification Product Code
GZI
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More FDA Info for this Product Code
Date Received
04/20/2007
Decision Date
07/05/2007
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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