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FDA 510(k) Application Details - K150010
Device Classification Name
More FDA Info for this Device
510(K) Number
K150010
Device Name
Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
Applicant
Cedic S.r.l.
Via Liberazione, 63/9
Peschiera Borromeo 20068 IT
Other 510(k) Applications for this Company
Contact
Tiziana Melis
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PIO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/02/2015
Decision Date
04/02/2015
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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