The following data is part of a premarket notification filed by Bemis Mfg. Co. with the FDA for Ight And Eleven Gallon Sharps And Chemotherapy Containers.
| Device ID | K950340 |
| 510k Number | K950340 |
| Device Name: | IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS |
| Classification | Container, Sharps |
| Applicant | BEMIS MFG. CO. 300 MILL ST. P.O. BOX 901 Sheboygen Falls, WI 53085 -0901 |
| Contact | John B Howell |
| Correspondent | John B Howell BEMIS MFG. CO. 300 MILL ST. P.O. BOX 901 Sheboygen Falls, WI 53085 -0901 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-27 |
| Decision Date | 1995-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10073088150704 | K950340 | 000 |
| 10073088148862 | K950340 | 000 |
| 10073088148879 | K950340 | 000 |
| 10073088148886 | K950340 | 000 |
| 10073088148893 | K950340 | 000 |
| 10073088149395 | K950340 | 000 |
| 10073088149401 | K950340 | 000 |
| 10073088149418 | K950340 | 000 |
| 10073088150698 | K950340 | 000 |
| 10073088148848 | K950340 | 000 |
| 10073088148855 | K950340 | 000 |