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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 K993687
Device Name UROVIEW 2800
Original Applicant
GE DEC MEDICAL SYSTEMS
384 wright brothers dr.
salt lake city,  UT  84116
Original Contact ted l parrot
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received11/01/1999
Decision Date 12/21/1999
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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