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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 Bldg.
915 Caron Rd., P.O. Box 48
Rochelle,  IL  61068
Applicant Contact JAMES W GHOLSON
Correspondent
Solarium Tanning Hut
Rochelle Professional Bldg.
915 Caron Rd., 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
Predetermined Change
Control Plan Authorized		 No
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