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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 K893475
Device Name UROVIEW II
Applicant
OEC-DIASONICS, INC.
2341 SOUTH 2300 WEST
P.O. BOX 25296
salt lake city,  UT  84119
Applicant Contact john w tolhurst
Correspondent
OEC-DIASONICS, INC.
2341 SOUTH 2300 WEST
P.O. BOX 25296
salt lake city,  UT  84119
Correspondent Contact john w tolhurst
Regulation Number892.1650
Classification Product Code
JAA  
Date Received05/04/1989
Decision Date 08/10/1989
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
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