Clearance Summary
SALINE SOLUTINE, STERILE received FDA 510(k) clearance under submission number K950560, sponsored by Busse Hospital Disposables, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1995-05-30.
- Submission: K950560
- Applicant / Sponsor: Busse Hospital Disposables, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1995-05-30
Classification & Regulation
This clearance is catalogued under FDA product code IGE and 21 CFR 864.4010, within the Pathology review panel as a Class I device.