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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 K860144
Device Name SUM TAN VI
Applicant
NAE, INC.
1647 BARTLETT RD.
MEMPHIS,  TN  38134
Applicant Contact FAYE LONGO
Correspondent
NAE, INC.
1647 BARTLETT RD.
MEMPHIS,  TN  38134
Correspondent Contact FAYE LONGO
Regulation Number878.4630
Classification Product Code
FTC  
Date Received01/15/1986
Decision Date 02/12/1986
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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