The following data is part of a premarket notification filed by Cedic S.r.l. with the FDA for Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector For Medication Port.
Device ID | K140581 |
510k Number | K140581 |
Device Name: | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT |
Classification | Enteral Specific Transition Connectors |
Applicant | CEDIC S.R.L. PIAZZA ALBANIA, 10 Rome, IT 00153 |
Contact | Roger Gray |
Correspondent | Roger Gray CEDIC S.R.L. PIAZZA ALBANIA, 10 Rome, IT 00153 |
Product Code | PIO |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-06 |
Decision Date | 2014-10-17 |
Summary: | summary |