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FDA 510(k) Application Details - K082927
Device Classification Name
Device, Muscle Monitoring
More FDA Info for this Device
510(K) Number
K082927
Device Name
Device, Muscle Monitoring
Applicant
BIO-RESEARCH ASSOCIATES, INC.
9275 NORTH 49TH STREET
SUITE 150
BROWN DEER, WI 53223 US
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Contact
JOHN RADKE
Other 510(k) Applications for this Contact
Regulation Number
890.1375
More FDA Info for this Regulation Number
Classification Product Code
KZM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2008
Decision Date
02/06/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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