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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 K913856
Device Name INFRARED HEAT LAMP MODEL NH-201
Applicant
National Health-Care Equipment, Inc.
144 E. Kingsbridge Rd.
Mount Vernon,  NY  11050
Applicant Contact PETER WINOCUR
Correspondent
National Health-Care Equipment, Inc.
144 E. Kingsbridge Rd.
Mount Vernon,  NY  11050
Correspondent Contact PETER WINOCUR
Regulation Number890.5500
Classification Product Code
ILY  
Date Received08/27/1991
Decision Date 11/29/1991
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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