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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K042793
Device Name ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
Applicant
SIEMENS MEDICAL SOLUTIONS, INC.
51 VALLEY STREAM PARKWAY
E-50
MALVERN,  PA  19355
Applicant Contact DEBBIE PEACOCK
Correspondent
SIEMENS MEDICAL SOLUTIONS, INC.
51 VALLEY STREAM PARKWAY
E-50
MALVERN,  PA  19355
Correspondent Contact DEBBIE PEACOCK
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received10/07/2004
Decision Date 10/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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