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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 K943545
Device Name CEILING SUSPENDED C-ARM SUPPORT MH-100
Applicant
SHIMADZU MEDICAL SYSTEMS
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Applicant Contact MICHAEL FISHBACK
Correspondent
SHIMADZU MEDICAL SYSTEMS
20101 SOUTH VERMONT AVE.
TORRANCE,  CA  90502 -1328
Correspondent Contact MICHAEL FISHBACK
Regulation Number892.1600
Classification Product Code
IZI  
Date Received07/21/1994
Decision Date 02/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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