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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K042461
Device Name KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
Applicant
KENDALL
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact PAUL W EVANS
Correspondent
KENDALL
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact PAUL W EVANS
Regulation Number880.5970
Classification Product Code
LJS  
Date Received09/10/2004
Decision Date 12/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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