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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 K924969
Device Name PHOTOTHERAPY TIMER
Applicant
National Biological Corp.
1532 Enterprise Pkwy.
Twinsburg,  OH  44087
Applicant Contact ARTHUR S GODDARD
Correspondent
National Biological Corp.
1532 Enterprise Pkwy.
Twinsburg,  OH  44087
Correspondent Contact ARTHUR S GODDARD
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/30/1992
Decision Date 02/23/1993
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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