The following data is part of a premarket notification filed by Sure-way Systems, Inc. with the FDA for Sure-way Reusable Sharps Container.
| Device ID | K992626 |
| 510k Number | K992626 |
| Device Name: | SURE-WAY REUSABLE SHARPS CONTAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SURE-WAY SYSTEMS, INC. 310 HARRY BRIDGES BLVD. Wilmington, CA 90744 |
| Contact | Gary Chilcott |
| Correspondent | Gary Chilcott SURE-WAY SYSTEMS, INC. 310 HARRY BRIDGES BLVD. Wilmington, CA 90744 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-05 |
| Decision Date | 1999-12-16 |