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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, fluoroscopic, image-intensified
510(k) Number K933473
Device Name CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM
Applicant
SHIMADZU CORP.
1 NISHINOKYO-KUWABARACHO
NAKAYGO-KU
KYOTO CITY 604 JAPAN,  JP
Applicant Contact HIROSLHI ISKHIHARA
Correspondent
SHIMADZU CORP.
1 NISHINOKYO-KUWABARACHO
NAKAYGO-KU
KYOTO CITY 604 JAPAN,  JP
Correspondent Contact HIROSLHI ISKHIHARA
Regulation Number892.1650
Classification Product Code
JAA  
Date Received07/15/1993
Decision Date 11/24/1993
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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