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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, muscle monitoring
510(k) Number K130158
Device Name M-SCAN
Applicant
BIO-RESEARCH ASSOCIATES, INC.
4555 W Schroeder Dr Ste 100
BROWN DEER,  WI  53223
Applicant Contact JOHN RADKE
Correspondent
BIO-RESEARCH ASSOCIATES, INC.
4555 W Schroeder Dr Ste 100
BROWN DEER,  WI  53223
Correspondent Contact JOHN RADKE
Regulation Number890.1375
Classification Product Code
KZM  
Date Received01/23/2013
Decision Date 07/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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