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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, multi format, radiological
510(k) Number K950610
Device Name FIKO FO;, TJER,A; O,AGER FTO-1000
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
333 LUDLOW ST.
P.O. BOX 120035
STAMFORD,  CT  06912 -0035
Applicant Contact OBERT A UZENOFF
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
333 LUDLOW ST.
P.O. BOX 120035
STAMFORD,  CT  06912 -0035
Correspondent Contact OBERT A UZENOFF
Regulation Number892.2040
Classification Product Code
LMC  
Date Received02/10/1995
Decision Date 04/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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