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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, fluoroscopic, image-intensified
510(k) Number K940295
Device Name UROVIEW MODEL 2600
Original Applicant
384 wright brothers dr.
salt lake city,  UT  84116
Original Contact thomas r meyers
Regulation Number892.1650
Classification Product Code
Date Received01/21/1994
Decision Date 08/22/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls