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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K081940
Device Name AVALON ELITE VASCULAR ACCESS KIT
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 Number870.1310
Classification Product Code
DRE  
Date Received07/08/2008
Decision Date 11/18/2008
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
Recalls CDRH Recalls
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