Clearance Summary
INSUFFLATION TUBING & FILTER received FDA 510(k) clearance under submission number K941094, sponsored by H & C Chemical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1994-05-10.
- Submission: K941094
- Applicant / Sponsor: H & C Chemical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1994-05-10
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.