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FDA 510(k) Application Details - K160614
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K160614
Device Name
Stimulator, Muscle, Powered
Applicant
RESTORATIVE THERAPIES INC.
1434 Fleet Street
Baltimore, MD 21231 US
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Contact
Andrew Barriskill
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
IPF
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More FDA Info for this Product Code
Date Received
03/03/2016
Decision Date
12/16/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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