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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 K943821
Device Name KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC
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 Received06/15/1994
Decision Date 08/22/1994
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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