510(k) K182235
K182235 is an FDA 510(k) premarket notification submitted by Bluestone Medical, Inc. for the device "OnSite Waste Sharps Container". The FDA issued a decision of Substantially Equivalent on May 20, 2019. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2019
- Date Received
- August 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Sharps
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type