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FDA 510(k) Application Details - K182794
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K182794
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
Medical Currents Ltd
8 Cuffe Lane
Dublin 2 D02W840 IE
Other 510(k) Applications for this Company
Contact
Louis Crowe
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
NGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2018
Decision Date
07/18/2019
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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