The following data is part of a premarket notification filed by Corpak Medsystems with the FDA for Farrell Valve System With Equilibrium Technology And Enfit Enteral Connectors.
| Device ID | K142012 |
| 510k Number | K142012 |
| Device Name: | FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | CORPAK MEDSYSTEMS 1001 ASBURY DR. Buffalo Grove, IL 60089 |
| Contact | Stephanie Wasielewki |
| Correspondent | Stephanie Wasielewki CORPAK MEDSYSTEMS 1001 ASBURY DR. Buffalo Grove, IL 60089 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-24 |
| Decision Date | 2014-11-20 |