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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 K895410
Device Name REMINGTON TANFASTIC HANDHELD TANNING WAND
Applicant
Remington Products Company, LLC
60 Main St.
Bridgeport,  CT  06604
Applicant Contact KATHLEEN IVANKO
Correspondent
Remington Products Company, LLC
60 Main St.
Bridgeport,  CT  06604
Correspondent Contact KATHLEEN IVANKO
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/06/1989
Decision Date 11/27/1989
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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