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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 K925821
Device Name COMFORTRON
Applicant
M. D. Supply, Inc.
4720 SE Fort King St.
Ocala,  FL  32671
Applicant Contact RICHARD O VOGEL
Correspondent
M. D. Supply, Inc.
4720 SE Fort King St.
Ocala,  FL  32671
Correspondent Contact RICHARD O VOGEL
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received11/17/1992
Decision Date 05/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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