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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 K860929
Device Name ULTRASUN 4000 FT & 15000-8 SUNTANNING UNIT
Applicant
MEDICAL DEVICE CONSULTANTS, INC.
45 WEST ST.
SUITE 2
ATTLEBORO,  MA  02703
Applicant Contact WILLIAM A MORTON
Correspondent
MEDICAL DEVICE CONSULTANTS, INC.
45 WEST ST.
SUITE 2
ATTLEBORO,  MA  02703
Correspondent Contact WILLIAM A MORTON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received03/11/1986
Decision Date 03/28/1986
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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