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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 K904428
Device Name PANOSOL II UAB-228
Applicant
NATIONAL BIOLOGICAL CORP.
1532 ENTERPRISE PKWY.
TWINSBURG,  OH  44087
Applicant Contact ARTHUR GODDARD
Correspondent
NATIONAL BIOLOGICAL CORP.
1532 ENTERPRISE PKWY.
TWINSBURG,  OH  44087
Correspondent Contact ARTHUR GODDARD
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/27/1990
Decision Date 12/24/1990
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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