Clearance Summary
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 received FDA 510(k) clearance under submission number K050355, sponsored by Tissue Science Laboratories, Plc. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2005-03-09.
- Submission: K050355
- Applicant / Sponsor: Tissue Science Laboratories, Plc
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.5980
- Decision date: 2005-03-09
Classification & Regulation
This clearance is catalogued under FDA product code PAI and 21 CFR 884.5980, within the Obstetrics/Gynecology review panel as a Class III device.