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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 K854171
Device Name I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC
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 11/06/1985
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
Predetermined Change
Control Plan Authorized		 No
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