Clearance Summary
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM received FDA 510(k) clearance under submission number K893452, sponsored by Warner-Lambert Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1989-06-22.
- Submission: K893452
- Applicant / Sponsor: Warner-Lambert Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1989-06-22
Classification & Regulation
This clearance is catalogued under FDA product code IZZ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.