510(k) K183398
K183398 is an FDA 510(k) premarket notification submitted by Aroa Biosurgery , Ltd. for the device "Endoform Restella". The FDA issued a decision of Substantially Equivalent on April 11, 2019. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Aroa Biosurgery , Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2019
- Date Received
- December 7, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type