Clearance Summary
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU received FDA 510(k) clearance under submission number K990913, sponsored by Laboratoires Prodimed. 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 1999-06-08.
- Submission: K990913
- Applicant / Sponsor: Laboratoires Prodimed
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6100
- Decision date: 1999-06-08
Classification & Regulation
This clearance is catalogued under FDA product code MQE and 21 CFR 884.6100, within the Obstetrics/Gynecology review panel as a Class II device.