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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Table, Radiologic
510(k) Number K874639
Device Name REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100
Applicant
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Applicant Contact HIROYUKI HATTORI,PHD
Correspondent
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Correspondent Contact HIROYUKI HATTORI,PHD
Regulation Number892.1980
Classification Product Code
KXJ  
Date Received11/12/1987
Decision Date 12/04/1987
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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