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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 K890585
Device Name INFRARED HEX
Applicant
Healthteam
625 Montrose Ave.
S. Plainfield,  NJ  07080
Applicant Contact JOHN CHAMBERS
Correspondent
Healthteam
625 Montrose Ave.
S. Plainfield,  NJ  07080
Correspondent Contact JOHN CHAMBERS
Regulation Number890.5500
Classification Product Code
ILY  
Date Received02/06/1989
Decision Date 08/22/1989
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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