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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K864653
Device Name MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS
Applicant
Rich-Mar Corp.
P.O. Box 879
Inola,  OK  74036
Applicant Contact DAVID RICHARDS
Correspondent
Rich-Mar Corp.
P.O. Box 879
Inola,  OK  74036
Correspondent Contact DAVID RICHARDS
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received11/28/1986
Decision Date 12/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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