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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, Stationary
510(k) Number K990715
Device Name SHIMADZU CEILING TUBE SUPPORT CH-30GH
Applicant
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502 -1328
Applicant Contact MICHAEL FISHBACK
Correspondent
Shimadzu Corp.
20101 S. Vermont Ave.
Torrance,  CA  90502 -1328
Correspondent Contact MICHAEL FISHBACK
Regulation Number892.1680
Classification Product Code
KPR  
Date Received03/04/1999
Decision Date 04/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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