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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, Angiographic
510(k) Number K090745
Device Name ARTIS ZEE / ZEEGOS WITH SW VC14
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
E-50
Malvern,  PA  19355
Applicant Contact GARY JOHNSON
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
E-50
Malvern,  PA  19355
Correspondent Contact GARY JOHNSON
Regulation Number892.1600
Classification Product Code
IZI  
Date Received03/20/2009
Decision Date 06/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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