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FDA 510(k) Application Details - K024010
Device Classification Name
Catheter, Retention Type, Balloon
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510(K) Number
K024010
Device Name
Catheter, Retention Type, Balloon
Applicant
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact
DAVID A OLSON
Other 510(k) Applications for this Contact
Regulation Number
876.5130
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Classification Product Code
EZL
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More FDA Info for this Product Code
Date Received
12/04/2002
Decision Date
06/11/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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