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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, Tomography, Computed
510(k) Number K991600
Device Name SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
Applicant
Siemens Corp.
186 Wood Ave. S.
Iselin,  NJ  08830
Applicant Contact ALICIA BUSTOS-JUERGENSEN
Correspondent
Siemens Corp.
186 Wood Ave. S.
Iselin,  NJ  08830
Correspondent Contact ALICIA BUSTOS-JUERGENSEN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/10/1999
Decision Date 06/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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