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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 K872604
Device Name HAND/FOOT 624-208
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 Received07/02/1987
Decision Date 07/24/1987
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
Recalls CDRH Recalls
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