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FDA 510(k) Application Details - K052168
Device Classification Name
Catheter, Retention Type, Balloon
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510(K) Number
K052168
Device Name
Catheter, Retention Type, Balloon
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact
LARA N SIMMONS
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
08/09/2005
Decision Date
02/16/2006
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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