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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 K042840
Device Name SHIMADZU COLLIMATOR R-20J
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact RANDAL WALKERI
Correspondent
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Correspondent Contact RANDAL WALKERI
Regulation Number892.1610
Classification Product Code
IZX  
Date Received10/14/2004
Decision Date 12/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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