The following data is part of a premarket notification filed by Bci, Inc. with the FDA for Sharps Container 18 Gallon.
| Device ID | K944121 |
| 510k Number | K944121 |
| Device Name: | SHARPS CONTAINER 18 GALLON |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BCI, INC. 170 CHANGEBRIDGE RD. UNIT A4-2 Montyville, NJ 07045 |
| Contact | Alan Larosee |
| Correspondent | Alan Larosee BCI, INC. 170 CHANGEBRIDGE RD. UNIT A4-2 Montyville, NJ 07045 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-23 |
| Decision Date | 1995-01-27 |