510(k) K183236
K183236 is an FDA 510(k) premarket notification submitted by Nanofiber Solutions, LLC for the device "Rotium Bioresorbable Wick". The FDA issued a decision of Substantially Equivalent on March 11, 2019. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Nanofiber Solutions, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2019
- Date Received
- November 20, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type