Clearance Summary
GLO-SPEC I, II AND III received FDA 510(k) clearance under submission number K020959, sponsored by Sol Weiss MD, Inc.. 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 2002-06-19.
- Submission: K020959
- Applicant / Sponsor: Sol Weiss MD, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2002-06-19
Classification & Regulation
This clearance is catalogued under FDA product code HIB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.