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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K965030
Device Name BRANNON ARTERIO-VENOUS PORTSYRINGE
Applicant
Vascular Logics, Inc.
5862 Bolsa Ave.
Suite 108
Huntington Beach,  CA  92649
Applicant Contact JAMES K BRANNON
Correspondent
Vascular Logics, Inc.
5862 Bolsa Ave.
Suite 108
Huntington Beach,  CA  92649
Correspondent Contact JAMES K BRANNON
Regulation Number880.5860
Classification Product Code
FMF  
Date Received12/17/1996
Decision Date 03/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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