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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, ultraviolet, dermatological
510(k) Number K862608
Device Name SPERTILITE PHOTOTHERAPY LAMP
Applicant
COOPER-HEWITT ELECTRIC CO.
ARENT,FOX,KINTNER,PLOTKIN,KAHN
1050 CONNECTICUT AVENUE, N. W.
WASHINGTON,  DC  20036
Applicant Contact P. S REICHERTZ
Correspondent
COOPER-HEWITT ELECTRIC CO.
ARENT,FOX,KINTNER,PLOTKIN,KAHN
1050 CONNECTICUT AVENUE, N. W.
WASHINGTON,  DC  20036
Correspondent Contact P. S REICHERTZ
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/08/1986
Decision Date 08/06/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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