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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Non-Tilting, Powered
510(k) Number K951315
Device Name CATHETERIZATION TABLE KS-60
Applicant
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact MICHAEL FISHBACK
Correspondent
Shimadzu Medical Systems
20101 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact MICHAEL FISHBACK
Regulation Number892.1980
Classification Product Code
IZZ  
Date Received03/23/1995
Decision Date 05/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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