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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 K014208
Device Name SSIR SYSTEM
Applicant
RUSSIAN-AMERICAN TECHNOLOGY ASSOCIATES, INC.
8303 S.W. FREEWAY, STE 835
HOUSTON,  TX  77074 -1601
Applicant Contact JOYCE HEINRICH
Correspondent
RUSSIAN-AMERICAN TECHNOLOGY ASSOCIATES, INC.
8303 S.W. FREEWAY, STE 835
HOUSTON,  TX  77074 -1601
Correspondent Contact JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/21/2001
Decision Date 07/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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