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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number K032827
Device Name KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
Applicant
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact GAIL CHRISTIE
Correspondent
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact GAIL CHRISTIE
Regulation Number864.9100
Classification Product Code
KSR  
Date Received09/10/2003
Decision Date 12/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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