Clearance Summary
STERILE SALINE SOLUTION received FDA 510(k) clearance under submission number K854155, sponsored by I M, 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 1985-12-10.
- Submission: K854155
- Applicant / Sponsor: I M, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 1985-12-10
Classification & Regulation
This clearance is catalogued under FDA product code KMJ and 21 CFR 880.6375, within the General Hospital review panel as a Class I device.