Clearance Summary
INSUFFLATION TUBING STERILE AND NON-STERILE received FDA 510(k) clearance under submission number K935639, sponsored by Charles Polo & Co., 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 1994-03-17.
- Submission: K935639
- Applicant / Sponsor: Charles Polo & Co., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1994-03-17
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.