The following data is part of a premarket notification filed by Bluestone Medical, Inc. with the FDA for Onsite Waste Sharps Container.
| Device ID | K182235 |
| 510k Number | K182235 |
| Device Name: | OnSite Waste Sharps Container |
| Classification | Container, Sharps |
| Applicant | Bluestone Medical, Inc. (DBA OnSite Waste Technologies, Inc.) 9 North Main Street East Hampton, NY 11937 |
| Contact | Jon Bricken |
| Correspondent | Jon Bricken Bluestone Medical, Inc. (DBA OnSite Waste Technologies, Inc.) 9 North Main Street East Hampton, NY 11937 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-17 |
| Decision Date | 2019-05-20 |