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FDA 510(k) Application Details - K053429
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K053429
Device Name
Catheter, Retention Type, Balloon
Applicant
ENTRACARE, LLC
11315 STRANG LINE RD.
LENEXA, KS 66215 US
Other 510(k) Applications for this Company
Contact
AL BOEDEKER
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2005
Decision Date
02/08/2006
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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