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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 K881923
Device Name ULTRAVIOLET RESOURCES INT'L MODEL 2-FS72
Applicant
ULTRAVIOLET RESOURCES INTL.
810 SHARON DR.
CLEVELAND,  OH  44145
Applicant Contact DOUGLAS H CLARKE
Correspondent
ULTRAVIOLET RESOURCES INTL.
810 SHARON DR.
CLEVELAND,  OH  44145
Correspondent Contact DOUGLAS H CLARKE
Regulation Number878.4630
Classification Product Code
FTC  
Date Received05/09/1988
Decision Date 07/07/1988
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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