Clearance Summary
PRESSURE IRRIGATING SYSTEM received FDA 510(k) clearance under submission number K936223, sponsored by Level 1 Technologies, 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 1994-05-12.
- Submission: K936223
- Applicant / Sponsor: Level 1 Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4680
- Decision date: 1994-05-12
Classification & Regulation
This clearance is catalogued under FDA product code GCY and 21 CFR 878.4680, within the General, Plastic Surgery review panel as a Class I device.