Clearance Summary
STRYKER T4 HYTREL (R) TOGAS received FDA 510(k) clearance under submission number K011755, sponsored by Stryker Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2001-06-22.
- Submission: K011755
- Applicant / Sponsor: Stryker Corp.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 2001-06-22
Classification & Regulation
This clearance is catalogued under FDA product code LYU and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.