Clearance Summary
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 received FDA 510(k) clearance under submission number K021193, sponsored by Fortune Medical Instrument Corp.. 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 2003-02-12.
- Submission: K021193
- Applicant / Sponsor: Fortune Medical Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4340
- Decision date: 2003-02-12
Classification & Regulation
This clearance is catalogued under FDA product code HDB and 21 CFR 884.4340, within the Obstetrics/Gynecology review panel as a Class II device.