The following data is part of a premarket notification filed by Corpak Medsystems with the FDA for Corflo Anti-iv Enteral Feeding Extension Set, Models 20-1006aiv-lb And 20-1030aiv-lb.
| Device ID | K083786 |
| 510k Number | K083786 |
| Device Name: | CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB |
| Classification | Tube, Feeding |
| Applicant | CORPAK MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Stephanie Wasielewski |
| Correspondent | Stephanie Wasielewski CORPAK MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-19 |
| Decision Date | 2009-02-20 |