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510(k) K190327

ENConnect 40 mm Screw Cap to ENPlus Adapter by Cedic S.R.L. — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2019
Date Received
February 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Tubes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To facilitate enteral specific connections.

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  • K162254 — Cedic Enteral ENFit Transition Connectors (May 4, 2017)
  • K150010 — Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port (April 2, 2015)
  • K140581 — CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSIT (October 17, 2014)
  • K072652 — ENTERAL FEEDING SPIKE ADAPTER (January 18, 2008)
  • K042129 — F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LU (January 27, 2005)

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