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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 K843647
Device Name MTI 1200, 401 & 3500
Applicant
MANUFACTURED TAN INTL.
P.O. BOX 162
S-570 80
VIRSERUM, 
Applicant Contact FREDRIK ROSENCR
Correspondent
MANUFACTURED TAN INTL.
P.O. BOX 162
S-570 80
VIRSERUM, 
Correspondent Contact FREDRIK ROSENCR
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/18/1984
Decision Date 10/25/1984
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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