Clearance Summary
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL received FDA 510(k) clearance under submission number K073684, sponsored by Sheffield Industries, Div. of Faria , Ltd.. 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 2008-05-22.
- Submission: K073684
- Applicant / Sponsor: Sheffield Industries, Div. of Faria , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 2008-05-22
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.