Clearance Summary
LAPARO-TENSER received FDA 510(k) clearance under submission number K970712, sponsored by L & T S.N.C. DI E. Lucini & C.. 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 1998-07-21.
- Submission: K970712
- Applicant / Sponsor: L & T S.N.C. DI E. Lucini & C.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1998-07-21
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.