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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K040679
Device Name RICH-MAR AUTOPRISM INFRARED LAMP
Applicant
Rich-Mar Corp.
15499 E. 590th Rd.
P.O. Box 879
Inola,  OK  74036
Applicant Contact DAVID RICHARDS
Correspondent
Rich-Mar Corp.
15499 E. 590th Rd.
P.O. Box 879
Inola,  OK  74036
Correspondent Contact DAVID RICHARDS
Regulation Number890.5500
Classification Product Code
ILY  
Date Received03/15/2004
Decision Date 05/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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