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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K964198
Device Name CAHSE AORTIC ROOT CANNULA
Applicant
Chase Medical, Inc.
1876 Firman Dr.
Richardson,  TX  75081
Applicant Contact BERT DAVIS
Correspondent
Chase Medical, Inc.
1876 Firman Dr.
Richardson,  TX  75081
Correspondent Contact BERT DAVIS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/21/1996
Decision Date 03/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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