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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 W. Wack Dr., Suite 1900
Chicago,  IL  60606
Applicant Contact JOSEPH R RADZIUS
Correspondent
M. D. Supply, Inc.
333 W. 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
Predetermined Change
Control Plan Authorized		 No
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