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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 K992660
Device Name URF DIGITAL - OT
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood avenue south
iselin,  NJ  08830
Original Contact malgorzata stanek
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received08/09/1999
Decision Date 11/05/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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