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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
Applicant
Ge Dec Medical Systems
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact TED L PARROT
Correspondent
Ge Dec Medical Systems
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Correspondent 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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