Clearance Summary
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS received FDA 510(k) clearance under submission number K881757, sponsored by Downs Surgical , Ltd.. 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 1988-07-15.
- Submission: K881757
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 1988-07-15
Classification & Regulation
This clearance is catalogued under FDA product code ETN and 21 CFR 874.1820, within the Ear, Nose, Throat review panel as a Class II device.