Clearance Summary
VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL received FDA 510(k) clearance under submission number K992081, sponsored by Suretex Prophylactics (India) , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1999-08-19.
- Submission: K992081
- Applicant / Sponsor: Suretex Prophylactics (India) , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1999-08-19
Classification & Regulation
This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.