The following data is part of a premarket notification filed by Mediflex Intl. with the FDA for Mediverse Parenteral Nutrition Bag.
| Device ID | K891077 |
| 510k Number | K891077 |
| Device Name: | MEDIVERSE PARENTERAL NUTRITION BAG |
| Classification | Container, I.v. |
| Applicant | MEDIFLEX INTL. 45 KULICK RD. Fairfield, NJ 07006 |
| Contact | Udine |
| Correspondent | Udine MEDIFLEX INTL. 45 KULICK RD. Fairfield, NJ 07006 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-01 |
| Decision Date | 1989-05-24 |