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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 K860370
Device Name SAFE SUN 700 HOME TANNING UNIT
Applicant
Safe Sun Corporation of America, Inc.
2770 Summer St.
Stamford,  CT  06905
Applicant Contact ROBERT L SCHWARTZ
Correspondent
Safe Sun Corporation of America, Inc.
2770 Summer St.
Stamford,  CT  06905
Correspondent Contact ROBERT L SCHWARTZ
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/03/1986
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
Predetermined Change
Control Plan Authorized		 No
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