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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Intensifying, Radiographic
510(k) Number K942235
Device Name KYOKKO GREEN SERIES INTENSIFYING SCREENS
Applicant
Fujifilm Medical System U.S.A., Inc.
333 Ludlow St.
P.O. Box 120035
Stamford,  CT  06912
Applicant Contact ROBERT A UZENOFF
Correspondent
Fujifilm Medical System U.S.A., Inc.
333 Ludlow St.
P.O. Box 120035
Stamford,  CT  06912
Correspondent Contact ROBERT A UZENOFF
Regulation Number892.1960
Classification Product Code
EAM  
Date Received05/09/1994
Decision Date 08/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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