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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K061799
Device Name QUADRATENS, MODEL QT-42
Applicant
BIO-RESEARCH ASSOCIATES, INC.
9275 NORTH 49TH STREET
SUITE 150
BROWN DEER,  WI  53223
Applicant Contact JOHN C RADKE
Correspondent
BIO-RESEARCH ASSOCIATES, INC.
9275 NORTH 49TH STREET
SUITE 150
BROWN DEER,  WI  53223
Correspondent Contact JOHN C RADKE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/26/2006
Decision Date 08/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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