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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 K013522
Device Name SOMATOM P30 CT SYSTEMS
Applicant
SIEMENS MEDICAL SYSTEMS, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact PRAVEEN NADKARNI
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact WOLFRAM GMELIN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/23/2001
Decision Date 11/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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