510(k) K171357
K171357 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corporation (Owner of Tei Biosciences) for the device "SurgiMend PRS Meshed, Revize-X". The FDA issued a decision of Substantially Equivalent on June 7, 2017. The device falls under product code OXH (Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2017
- Date Received
- May 9, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.