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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 K827890
Device Name FOLDALITE UNIT
Applicant
NATIONAL BIOLOGICAL CORP.
1532 ENTERPRISE PKWY.
TWINSBURG,  OH  44087
Correspondent
NATIONAL BIOLOGICAL CORP.
1532 ENTERPRISE PKWY.
TWINSBURG,  OH  44087
Regulation Number878.4630
Classification Product Code
FTC  
Date Received08/11/1982
Decision Date 08/23/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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