510(k) K121139
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2012
- Date Received
- April 16, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Deployer
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).