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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K040139
Device Name ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER
Applicant
ENDOBIONICS, INC.
3077 TEAGARDEN STREET
SAN LEANDRO,  CA  94577 -5720
Applicant Contact KIRK P SEWARD
Correspondent
KEMA QUALITY B.V.
P.O. BOX 5185
6802 ED ARNHEM
ARNHEM,  NL
Correspondent Contact J.A. VAN VUGT
Regulation Number870.1210
Classification Product Code
KRA  
Date Received01/22/2004
Decision Date 02/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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