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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 K051046
Device Name PAINACEA MODEL XR8 INFRARED HEAT LAMP
Applicant
ATLANTIS LUMINESCENT PRODUCTS, LLC
11874 SOUTH EVELYN CIRCLE
HOUSTON,  TX  77071
Applicant Contact JAMES HARVEY KNAUSS
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received04/25/2005
Decision Date 05/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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