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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 K081820
Device Name AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR
Applicant
AVALON LABORATORIES, LLC
5200 CRYSTAL WATER DR.
AUSTIN,  TX  78735
Applicant Contact DAVID C FURR
Correspondent
AVALON LABORATORIES, LLC
5200 CRYSTAL WATER DR.
AUSTIN,  TX  78735
Correspondent Contact DAVID C FURR
Regulation Number870.4210
Classification Product Code
DWF  
Date Received06/27/2008
Decision Date 10/06/2008
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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