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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 K032280
Device Name SIREMOBIL ISO-C 3D
Applicant
Siemens AG
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact NEALIE HARTMAN
Correspondent
Siemens AG
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact NEALIE HARTMAN
Regulation Number892.1720
Classification Product Code
IZL  
Date Received07/24/2003
Decision Date 09/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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