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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 K861963
Device Name ULTRALITE HF1236 HAND AND FOOT SYSTEM
Applicant
ULTRALITE
390 FARMER CT.
LAWRENCEVILLE,  GA  30245
Applicant Contact WILLIAM C MCMILLAN
Correspondent
ULTRALITE
390 FARMER CT.
LAWRENCEVILLE,  GA  30245
Correspondent Contact WILLIAM C MCMILLAN
Regulation Number878.4630
Classification Product Code
FTC  
Date Received05/20/1986
Decision Date 06/25/1986
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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