Clearance Summary
GOLD GATORS received FDA 510(k) clearance under submission number K903729, sponsored by Lead-Lok, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-09-14.
- Submission: K903729
- Applicant / Sponsor: Lead-Lok, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4330
- Decision date: 1990-09-14
Classification & Regulation
This clearance is catalogued under FDA product code DRY and 21 CFR 870.4330, within the Cardiovascular review panel as a Class II device.