510(k) K192112
K192112 is an FDA 510(k) premarket notification submitted by International Life Sciences for the device "FlexBand Plus". The FDA issued a decision of Substantially Equivalent on September 27, 2019. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. International Life Sciences has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2019
- Date Received
- August 5, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type