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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 K864714
Device Name INFRALUX HEAT LAMP
Applicant
Infralux International, Inc.
98 Clinton Rd.
Fairfield,  NJ  07006
Applicant Contact VON WINCKLER
Correspondent
Infralux International, Inc.
98 Clinton Rd.
Fairfield,  NJ  07006
Correspondent Contact VON WINCKLER
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/03/1986
Decision Date 03/12/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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