The following data is part of a premarket notification filed by Bemis Mfg. Co. with the FDA for Chemotherapy Container.
| Device ID | K911576 |
| 510k Number | K911576 |
| Device Name: | CHEMOTHERAPY CONTAINER |
| Classification | Container, I.v. |
| Applicant | BEMIS MFG. CO. 300 MILL ST. Sheboygan Falls, WI 53085 |
| Contact | John B Howell |
| Correspondent | John B Howell BEMIS MFG. CO. 300 MILL ST. Sheboygan Falls, WI 53085 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-08 |
| Decision Date | 1991-07-05 |