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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 K081933
Device Name AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
Applicant
Avalon Laboratories, LLC
2610 E Homestead Place
Rancho Dominguez,  CA  90220
Applicant Contact LEE WIRTH
Correspondent
Avalon Laboratories, LLC
2610 E Homestead Place
Rancho Dominguez,  CA  90220
Correspondent Contact LEE WIRTH
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/07/2008
Decision Date 10/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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