The following data is part of a premarket notification filed by Daniels Corporation Pty, Inc. with the FDA for Sharpsmart Disposable Sharps Container, Model S2.
| Device ID | K091736 |
| 510k Number | K091736 |
| Device Name: | SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 |
| Classification | Container, Sharps |
| Applicant | DANIELS CORPORATION PTY, INC. 2133-126 UPTON DRIVE SUITE 436 Virginia Beach, VA 23454 |
| Contact | Andrea Arredondo |
| Correspondent | Andrea Arredondo DANIELS CORPORATION PTY, INC. 2133-126 UPTON DRIVE SUITE 436 Virginia Beach, VA 23454 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-11 |
| Decision Date | 2009-10-30 |
| Summary: | summary |