510(k) K190663
K190663 is an FDA 510(k) premarket notification submitted by PAJUNK GmbH Medizintechnologie for the device "Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6". The FDA issued a decision of Substantially Equivalent on June 17, 2019. The device falls under product code BSN (Filter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5130. PAJUNK GmbH Medizintechnologie has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2019
- Date Received
- March 15, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Conduction, Anesthetic
- Device Class
- Class II
- Regulation Number
- 868.5130
- Review Panel
- AN
- Submission Type