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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 K924077
Device Name HANDISOL
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 Received08/12/1992
Decision Date 11/20/1992
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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