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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 K854707
Device Name SUNTAINNING BOOTH
Applicant
David Connell
69 Homefield Ave.
Providence,  RI  02908
Applicant Contact DAVID CONNELL
Correspondent
David Connell
69 Homefield Ave.
Providence,  RI  02908
Correspondent Contact DAVID CONNELL
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/20/1985
Decision Date 01/30/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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