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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 K854004
Device Name FLUORESCENT T12 UVA TANNING LAMP
Applicant
LIGHT SOURCES, INC.
P.O. BOX 569
410 MAIN ST.
ANSONIA,  CT  06401
Applicant Contact GENE CZAKO
Correspondent
LIGHT SOURCES, INC.
P.O. BOX 569
410 MAIN ST.
ANSONIA,  CT  06401
Correspondent Contact GENE CZAKO
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/30/1985
Decision Date 10/29/1985
Decision Substantially Equivalent (SESE)
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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