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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 K051816
Device Name LUMIWAVE 1X4 INFRARED THERAPY DEVICE
Applicant
Biocare Systems, Inc.
518 17th St.
Suite 1350
Denver,  CO  80202
Applicant Contact CLAY ANSELMO
Correspondent
Biocare Systems, Inc.
518 17th St.
Suite 1350
Denver,  CO  80202
Correspondent Contact CLAY ANSELMO
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/05/2005
Decision Date 08/26/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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