The following data is part of a premarket notification filed by Bemis Mfg. Co. with the FDA for Bemis Two Gallon Chemotherapy Container.
| Device ID | K964858 |
| 510k Number | K964858 |
| Device Name: | BEMIS TWO GALLON CHEMOTHERAPY CONTAINER |
| Classification | Container, Sharps |
| 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 | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-04 |
| Decision Date | 1997-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10073088149371 | K964858 | 000 |
| 10073088149364 | K964858 | 000 |