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510(k) K162254

Device
Cedic Enteral ENFit Transition Connectors
Applicant
CEDIC S.R.L.
510(k) number
K162254
Product code
PIO  
Decision
Substantially Equivalent (SESE)
Decision date
2017-05-04
Date received
2016-08-10
Regulation
876.5980
Classification name
Enteral Specific Transition Connectors
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TIZIANA MELIS
Address
Via Liberazione, 63/9 Peschiera Borromeo IT 20068 20068

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PIO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl2024-01-22
K233190ENFit AdaptorJiangsu Caina Medical Co.,Ltd2024-01-18
K220165Enteral Transition AdaptorGBUK Group, Ltd.2022-10-21
K151237Nutrisafe 2- ENFit AdaptorVygon2016-02-09
K151628Medline ENFit ConnectorsMedline Industries, Inc.2015-07-24
K150034AMT Enteral Transition AdaptersApplied Medical Technology, Inc.2015-06-09
K150010Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortCedic S.R.L.2015-04-02
K140581CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORTCedic S.R.L.2014-10-17

Legacy Summary#

summary

FDA Review#

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