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FDA 510(k) Application Details - K072294
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
More FDA Info for this Device
510(K) Number
K072294
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
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Classification Product Code
NGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/16/2007
Decision Date
10/25/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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