Clearance Summary
IRRIGATION KIT received FDA 510(k) clearance under submission number K883506, sponsored by L H M Ent., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1988-12-13.
- Submission: K883506
- Applicant / Sponsor: L H M Ent., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6960
- Decision date: 1988-12-13
Classification & Regulation
This clearance is catalogued under FDA product code KYZ and 21 CFR 880.6960, within the General Hospital review panel as a Class I device.