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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 K955395
Device Name DAR-2400-15B/30B
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 Received11/24/1995
Decision Date 12/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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