Clearance Summary
STERILE SALINE SOLUTION received FDA 510(k) clearance under submission number K102165, sponsored by Cachet Pharmaceuticals Pvt. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2011-01-19.
- Submission: K102165
- Applicant / Sponsor: Cachet Pharmaceuticals Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2011-01-19
Classification & Regulation
This clearance is catalogued under FDA product code LPN and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.