The following data is part of a premarket notification filed by Kabivitrum, Inc. with the FDA for The I.v. Bag.
| Device ID | K844664 |
| 510k Number | K844664 |
| Device Name: | THE I.V. BAG |
| Classification | Container, I.v. |
| Applicant | KABIVITRUM, INC. P.O. BOX 1550 Berkeley, CA 94701 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi KABIVITRUM, INC. P.O. BOX 1550 Berkeley, CA 94701 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-30 |
| Decision Date | 1985-05-06 |