Clearance Summary
TISSU TRANS HARVEST TUBING received FDA 510(k) clearance under submission number K092022, sponsored by Shippert Medical Technologies Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-08-17.
- Submission: K092022
- Applicant / Sponsor: Shippert Medical Technologies Corp.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6960
- Decision date: 2009-08-17
Classification & Regulation
This clearance is catalogued under FDA product code KYZ and 21 CFR 880.6960, within the General Hospital review panel as a Class I device.