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FDA 510(k) Application Details - K043605
Device Classification Name
Dilator, Esophageal
More FDA Info for this Device
510(K) Number
K043605
Device Name
Dilator, Esophageal
Applicant
CORDIS EUROPA, N.V.
OOSTEINDE 8
RODEN NL-9301 LJ NL
Other 510(k) Applications for this Company
Contact
HARM HOVINGA
Other 510(k) Applications for this Contact
Regulation Number
876.5365
More FDA Info for this Regulation Number
Classification Product Code
KNQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/30/2004
Decision Date
02/04/2005
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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