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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Interferential Current Therapy
510(k) Number K952089
Device Name RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
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 Number882.5890
Classification Product Code
LIH  
Subsequent Product Codes
GZJ   IMG   IMI   IPF  
Date Received05/03/1995
Decision Date 08/11/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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