Clearance Summary
UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA, received FDA 510(k) clearance under submission number K800518, sponsored by Kopharm, 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 1980-03-20.
- Submission: K800518
- Applicant / Sponsor: Kopharm, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1980-03-20
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.