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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 K900885
Device Name FUJI MEDICAL LASER IMAGER
Applicant
Fujifilm Medical System U.S.A., Inc.
90 Viaduct Rd.
P.O. Box 4960
Stamford,  CT  06907
Applicant Contact ROBERT A UZENOFF
Correspondent
Fujifilm Medical System U.S.A., Inc.
90 Viaduct Rd.
P.O. Box 4960
Stamford,  CT  06907
Correspondent Contact ROBERT A UZENOFF
Regulation Number892.2040
Classification Product Code
LMC  
Date Received02/26/1990
Decision Date 03/23/1990
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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