Clearance Summary
Harmony Latex Dam, Harmony Non-Latex Dam received FDA 510(k) clearance under submission number K203727, sponsored by Pamco Distributing, 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 2021-08-05.
- Submission: K203727
- Applicant / Sponsor: Pamco Distributing, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2021-08-05
Classification & Regulation
This clearance is catalogued under FDA product code MSC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.