Clearance Summary
EPCOM VCU-1 VACUUM SYSTEM & CURETTE received FDA 510(k) clearance under submission number K831112, sponsored by Epcom Medical Systems, Inc.. 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 1983-06-30.
- Submission: K831112
- Applicant / Sponsor: Epcom Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5070
- Decision date: 1983-06-30
Classification & Regulation
This clearance is catalogued under FDA product code HHI and 21 CFR 884.5070, within the Obstetrics/Gynecology review panel as a Class II device.