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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 K070934
Device Name PANOSOL II TRU-BLU, MODEL UBL-417
Applicant
National Biological Corp.
1532 Enterprise Pkwy.
Twinsburg,  OH  44087
Applicant Contact GEORGE KRINER
Correspondent
National Biological Corp.
1532 Enterprise Pkwy.
Twinsburg,  OH  44087
Correspondent Contact GEORGE KRINER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/03/2007
Decision Date 05/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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