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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 K860856
Device Name SILGMANN SOLARIUM SUN-MOBIL MODEL 0918
Applicant
SOLARIUM TANNING HUT
ROCHELLE PROFESSIONAL BUILDING
915 CARON ROAD, P.O. BOX 48
ROCHELLE,  IL  61068
Applicant Contact JAMES W GHOLSON
Correspondent
SOLARIUM TANNING HUT
ROCHELLE PROFESSIONAL BUILDING
915 CARON ROAD, P.O. BOX 48
ROCHELLE,  IL  61068
Correspondent Contact JAMES W GHOLSON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received03/07/1986
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
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