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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 K854170
Device Name I.S.M. PRODUCT FAMILY MODEL R3600C
Applicant
INTL. SOLARIUM MANUFACTURER, INC.
7005 TUJUNGA AVE.
NORTH HOLLYWOOD,  CA  91605
Applicant Contact ERNEST B KNAPP
Correspondent
INTL. SOLARIUM MANUFACTURER, INC.
7005 TUJUNGA AVE.
NORTH HOLLYWOOD,  CA  91605
Correspondent Contact ERNEST B KNAPP
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/15/1985
Decision Date 11/08/1985
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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