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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 K042646
Device Name DYNACT
Applicant
Siemens Medical Systems, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Applicant Contact ANA LADINO
Correspondent
Siemens Medical Systems, Inc.
51 Valley Stream Pkwy.
Mavern,  PA  19355
Correspondent Contact ANA LADINO
Regulation Number892.1600
Classification Product Code
IZI  
Date Received09/28/2004
Decision Date 10/19/2004
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
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