Clearance Summary
CARL ZEISS INN MYRINGOTOMY TUBE LINE received FDA 510(k) clearance under submission number K811698, sponsored by James L. Geraci & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1981-08-31.
- Submission: K811698
- Applicant / Sponsor: James L. Geraci & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3880
- Decision date: 1981-08-31
Classification & Regulation
This clearance is catalogued under FDA product code ETD and 21 CFR 874.3880, within the Ear, Nose, Throat review panel as a Class II device.