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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K944004
Device Name VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)
Applicant
Endosonics Corp.
3078-B Prospect Park Dr.
Rancho Cordova,  CA  95670
Applicant Contact ADAM D SAVAKUS
Correspondent
Endosonics Corp.
3078-B Prospect Park Dr.
Rancho Cordova,  CA  95670
Correspondent Contact ADAM D SAVAKUS
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received08/16/1994
Decision Date 05/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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