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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K904051
Device Name RICH-MAR MODEL V ULTRASOUND
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 Number890.5300
Classification Product Code
IMI  
Date Received09/04/1990
Decision Date 01/14/1991
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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