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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 K971452
Device Name MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE
Applicant
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact JEFFREY W KOONTZ
Correspondent
Siemens Medical Solutions USA, Inc.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact JEFFREY W KOONTZ
Regulation Number892.1980
Classification Product Code
IZZ  
Date Received04/21/1997
Decision Date 05/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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