The following data is part of a premarket notification filed by Bemis Mfg. Co. with the FDA for Bemis Two Gallon Sharps Container.
| Device ID | K965248 |
| 510k Number | K965248 |
| Device Name: | BEMIS TWO GALLON SHARPS CONTAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| 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 | 1997-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10073088151039 | K965248 | 000 |
| 10073088148770 | K965248 | 000 |
| 10073088148763 | K965248 | 000 |
| 10073088148794 | K965248 | 000 |