HealthBeacon HB2 Sharps Bin
FDA 510(k) clearance K172719 · decided 2018-05-11
Clearance details
- K-number
- K172719
- Device name
- HealthBeacon HB2 Sharps Bin
- Applicant
- Healthbeacon, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-08
- Decision date
- 2018-05-11
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dublin, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.