Clearance Summary
AMNIGLOVE & AMNICOT received FDA 510(k) clearance under submission number K850758, sponsored by Go Medical Industries Pty. , Ltd.. 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 1985-04-15.
- Submission: K850758
- Applicant / Sponsor: Go Medical Industries Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1985-04-15
Classification & Regulation
This clearance is catalogued under FDA product code HGE and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.