Clearance Summary
WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED received FDA 510(k) clearance under submission number K971028, sponsored by Worlds-Best Gummivarefabrik A/S. 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 1998-03-02.
- Submission: K971028
- Applicant / Sponsor: Worlds-Best Gummivarefabrik A/S
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1998-03-02
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.