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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, Angiographic
510(k) Number K062360
Device Name BRANSIST SAFIRE
Applicant
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact RANDAL WALKER
Correspondent
SHIMADZU CORP.
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Correspondent Contact RANDAL WALKER
Regulation Number892.1600
Classification Product Code
IZI  
Date Received08/14/2006
Decision Date 10/05/2006
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
Recalls CDRH Recalls
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