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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, Mobile
510(k) Number K033238
Device Name MOBILETTE XP AND MOBILETT XPHYBRID
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 Number892.1720
Classification Product Code
IZL  
Date Received10/06/2003
Decision Date 11/14/2003
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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