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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K875377
Device Name SHIMADZU MAMMOGRAPHIC STAND MR-30
Applicant
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Applicant Contact HIROYUKI HATTORI
Correspondent
Shimadzu Precision Instruments, Inc.
20410 Earl St.
Torrance,  CA  90503
Correspondent Contact HIROYUKI HATTORI
Regulation Number892.1710
Classification Product Code
IZH  
Date Received12/31/1987
Decision Date 02/12/1988
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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