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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 K925054
Device Name INFRARED LAMP
Applicant
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Applicant Contact STEPHEN WHITTENBURG
Correspondent
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Correspondent Contact STEPHEN WHITTENBURG
Regulation Number890.5500
Classification Product Code
ILY  
Date Received10/06/1992
Decision Date 06/29/1993
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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