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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Manual, Radiographic
510(k) Number K031771
Device Name SHIMADZU COLLIMATOR R-30H
Applicant
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact TAKESHI OZAKI
Correspondent
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact TAKESHI OZAKI
Regulation Number892.1610
Classification Product Code
IZX  
Date Received06/09/2003
Decision Date 08/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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