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FDA 510(k) Application Details - K151903
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K151903
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
BIO-MEDICAL RESEARCH LTD.
PARKMORE BUSINESS PARK WEST
GALWAY IE
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Contact
ANNE-MARIE KEENAN
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
07/10/2015
Decision Date
11/06/2015
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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