Clearance Summary
NEO-THOR THORACOSTOMY KIT received FDA 510(k) clearance under submission number K913541, sponsored by Intl. Medical Devices , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1992-04-09.
- Submission: K913541
- Applicant / Sponsor: Intl. Medical Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1992-04-09
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.