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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 K040577
Device Name SOMATOM PROJECT P30L
Applicant
SIEMENS MEDICAL SYSTEMS, INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355 -1406
Applicant Contact NEALIE HARTMAN
Correspondent
SIEMENS MEDICAL SYSTEMS, INC.
51 VALLEY STREAM PARKWAY
MALVERN,  PA  19355 -1406
Correspondent Contact NEALIE HARTMAN
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/04/2004
Decision Date 03/22/2004
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
Recalls CDRH Recalls
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