Clearance Summary
SAVE-T-BREATH AMBILICAL CORD CLAMP received FDA 510(k) clearance under submission number K933763, sponsored by Save-T-Breath Distributors C.C.. 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 1994-08-29.
- Submission: K933763
- Applicant / Sponsor: Save-T-Breath Distributors C.C.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-08-29
Classification & Regulation
This clearance is catalogued under FDA product code HFW and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.