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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 K862092
Device Name COMFORTRON
Applicant
M. D. SUPPLY, INC.
333 WEST WACK DR., SUITE 1900
CHICAGO,  IL  60606
Applicant Contact JOSEPH R RADZIUS
Correspondent
M. D. SUPPLY, INC.
333 WEST WACK DR., SUITE 1900
CHICAGO,  IL  60606
Correspondent Contact JOSEPH R RADZIUS
Regulation Number890.1375
Classification Product Code
KZM  
Date Received06/02/1986
Decision Date 10/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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