Clearance Summary
'EXMOOR' ZOELLNER SUCKER ENDS received FDA 510(k) clearance under submission number K864937, sponsored by Exmoor Plastics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1987-03-30.
- Submission: K864937
- Applicant / Sponsor: Exmoor Plastics , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1987-03-30
Classification & Regulation
This clearance is catalogued under FDA product code JOL and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.