Clearance Summary
RESPIR GARD-II FACE MASK CORRUGATED TUBING received FDA 510(k) clearance under submission number K853056, sponsored by Marquest Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1985-08-07.
- Submission: K853056
- Applicant / Sponsor: Marquest Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1390
- Decision date: 1985-08-07
Classification & Regulation
This clearance is catalogued under FDA product code IYT and 21 CFR 892.1390, within the Radiology review panel as a Class II device.