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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K911384
Device Name CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600
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 Number870.2330
Classification Product Code
DXK  
Date Received03/28/1991
Decision Date 06/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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