Clearance Summary
TRACHEOSTOMY CARE KIT received FDA 510(k) clearance under submission number K952416, sponsored by Medi-Flex Hospital Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1995-08-09.
- Submission: K952416
- Applicant / Sponsor: Medi-Flex Hospital Products, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 1995-08-09
Classification & Regulation
This clearance is catalogued under FDA product code BTO and 21 CFR 868.5800, within the Anesthesiology review panel as a Class II device.