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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 K845028
Device Name MARTANIQUE 7-TUBE RUVA HOME SOLARIUM
Applicant
Bainbridge Trading Co., Ltd.
210 Sound Beach Ave.
Old Greenwich,  CT  06870
Applicant Contact ANDREW R HUSTON
Correspondent
Bainbridge Trading Co., Ltd.
210 Sound Beach Ave.
Old Greenwich,  CT  06870
Correspondent Contact ANDREW R HUSTON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/27/1984
Decision Date 01/14/1985
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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