510(k) K192349
K192349 is an FDA 510(k) premarket notification submitted by Next Science, LLC for the device "Bactisure Wound Lavage". The FDA issued a decision of Substantially Equivalent on January 23, 2020. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Next Science, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2020
- Date Received
- August 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lavage, Jet
- Device Class
- Class II
- Regulation Number
- 880.5475
- Review Panel
- HO
- Submission Type