The following data is part of a premarket notification filed by Corpak Medsystems with the FDA for Corflo Anti Iv Enteral Feeding Set, Model: 20-1060aiv-s.
Device ID | K083791 |
510k Number | K083791 |
Device Name: | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S |
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 | 2009-03-04 |