Clearance Summary
OMNI-JUG received FDA 510(k) clearance under submission number K952200, sponsored by Waterstone Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1995-06-29.
- Submission: K952200
- Applicant / Sponsor: Waterstone Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1995-06-29
Classification & Regulation
This clearance is catalogued under FDA product code KDG and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.