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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 K903371
Device Name CATHETERIZATION C-ARM SUPPORT MH-51B(F)
Applicant
SHIMADZU MEDICAL SYSTEMS
101 WEST WALNUT ST.
GARDENIA,  CA  90248
Applicant Contact DE MINT
Correspondent
SHIMADZU MEDICAL SYSTEMS
101 WEST WALNUT ST.
GARDENIA,  CA  90248
Correspondent Contact DE MINT
Regulation Number892.1600
Classification Product Code
IZI  
Date Received07/26/1990
Decision Date 11/29/1990
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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