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FDA 510(k) Application Details - K052969
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
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510(K) Number
K052969
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK WEST
GALWAY IE
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Contact
MICHAEL O'SULLIVAN
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Regulation Number
890.5850
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Classification Product Code
NGX
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More FDA Info for this Product Code
Date Received
10/21/2005
Decision Date
11/16/2005
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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