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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 K852957
Device Name SAHARA SUNBED
Applicant
SAHARA SUN BEDS., INC.
3241 15TH ST. SO.
FARGO,  ND  58103
Applicant Contact LARRY VILLELLA
Correspondent
SAHARA SUN BEDS., INC.
3241 15TH ST. SO.
FARGO,  ND  58103
Correspondent Contact LARRY VILLELLA
Regulation Number878.4630
Classification Product Code
FTC  
Date Received07/12/1985
Decision Date 07/29/1985
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
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