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FDA 510(k) Application Details - K053468
Device Classification Name
Stimulator, Neuromuscular, External Functional
More FDA Info for this Device
510(K) Number
K053468
Device Name
Stimulator, Neuromuscular, External Functional
Applicant
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
555 13TH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact
JONATHAN S KAHN
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
12/13/2005
Decision Date
07/07/2006
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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