Clearance Summary
SAFE KNIGHTS received FDA 510(k) clearance under submission number K955183, sponsored by L & N Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1997-02-11.
- Submission: K955183
- Applicant / Sponsor: L & N Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1997-02-11
Classification & Regulation
This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.