510(k) K031188
K031188 is an FDA 510(k) premarket notification submitted by Tei Biosciences, Inc. for the device "ORTHOMEND". The FDA issued a decision of Substantially Equivalent on June 27, 2003. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Tei Biosciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2003
- Date Received
- April 15, 2003
- Clearance Type
- Abbreviated
- 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