The following data is part of a premarket notification filed by Healthbeacon Ltd with the FDA for Healthbeacon Hb2 Sharps Bin.
| Device ID | K172719 |
| 510k Number | K172719 |
| Device Name: | HealthBeacon HB2 Sharps Bin |
| Classification | Container, Sharps |
| Applicant | HealthBeacon Ltd Unit 20, Naas Road Business Park, Muirfield Drive Dublin, IE Dublin 12 |
| Contact | Joyce Power |
| Correspondent | Joyce Power HealthBeacon Ltd Unit 20, Naas Road Business Park, Muirfield Drive Dublin, IE Dublin 12 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-08 |
| Decision Date | 2018-05-11 |
| Summary: | summary |