Clearance Summary
CAMERA COVER WITH TEAR TIP received FDA 510(k) clearance under submission number K940152, sponsored by Hydro-Med Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1994-10-28.
- Submission: K940152
- Applicant / Sponsor: Hydro-Med Products, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1994-10-28
Classification & Regulation
This clearance is catalogued under FDA product code FEM and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.