Clearance Summary
PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION received FDA 510(k) clearance under submission number K000265, sponsored by Primary Care Solutions, 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 2001-07-12.
- Submission: K000265
- Applicant / Sponsor: Primary Care Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 2001-07-12
Classification & Regulation
This clearance is catalogued under FDA product code JOL and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.