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FDA 510(k) Application Details - K083105
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K083105
Device Name
Stimulator, Muscle, Powered
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
IPF
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More FDA Info for this Product Code
Date Received
10/20/2008
Decision Date
07/24/2009
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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