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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 K964391
Device Name CHASE LEFT VENT SAFETY VALVE
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 Received11/04/1996
Decision Date 05/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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