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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 K860117
Device Name KRYPTOSOL (SUN LAMP)
Applicant
TRADEMARK IMPORTS
P.O. BOX 4877
GREENVILLE,  SC  29608
Applicant Contact JOHN C MARLER
Correspondent
TRADEMARK IMPORTS
P.O. BOX 4877
GREENVILLE,  SC  29608
Correspondent Contact JOHN C MARLER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received01/13/1986
Decision Date 01/30/1986
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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