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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K984409
Device Name ELK LASER FILM DIGITIZER
Applicant
NISHIMOTO SANGYO CO., LTD.
16303 PANORAMIC WAY
SAN LEANDRO,  CA  94578 -1116
Applicant Contact GARY J ALLSEBROOK
Correspondent
NISHIMOTO SANGYO CO., LTD.
16303 PANORAMIC WAY
SAN LEANDRO,  CA  94578 -1116
Correspondent Contact GARY J ALLSEBROOK
Regulation Number892.2030
Classification Product Code
LMA  
Date Received12/09/1998
Decision Date 02/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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