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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, Tilting
510(k) Number K925175
Device Name SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
Applicant
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Applicant Contact DE MINT
Correspondent
Shimadzu Medical Systems
101 W. Walnut St.
Gardena,  CA  90248
Correspondent Contact DE MINT
Regulation Number892.1980
Classification Product Code
IXR  
Date Received10/13/1992
Decision Date 11/27/1992
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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