The following data is part of a premarket notification filed by Stedim, Inc. with the FDA for Dual Compartment Tpn Bag 3 Liter.
| Device ID | K911567 |
| 510k Number | K911567 |
| Device Name: | DUAL COMPARTMENT TPN BAG 3 LITER |
| Classification | Container, I.v. |
| Applicant | STEDIM, INC. 2717 NO. MAIN ST. SUITE 5 Walnut Creek, CA 94596 |
| Contact | Bryan Krause |
| Correspondent | Bryan Krause STEDIM, INC. 2717 NO. MAIN ST. SUITE 5 Walnut Creek, CA 94596 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-09 |
| Decision Date | 1991-08-02 |