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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 K931261
Device Name SPECTROPAD SYSTEM
Applicant
Smi
11111 D W. 8th Ave.
Lakewood,  CO  80215
Applicant Contact JOE MARKHAM
Correspondent
Smi
11111 D W. 8th Ave.
Lakewood,  CO  80215
Correspondent Contact JOE MARKHAM
Regulation Number890.5500
Classification Product Code
ILY  
Date Received03/12/1993
Decision Date 03/31/1994
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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