Clearance Summary
NORTEC STERILE WATER FOR DEVICE IRRIGATION received FDA 510(k) clearance under submission number K925593, sponsored by North American Sterilization & Packaging Co.. 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 1993-12-03.
- Submission: K925593
- Applicant / Sponsor: North American Sterilization & Packaging Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1993-12-03
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.