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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 K010942
Device Name U04
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood avenue south
iselin,  NJ  08830
Original Contact amy shaw hosler
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received03/29/2001
Decision Date 04/12/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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