Clearance Summary
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D received FDA 510(k) clearance under submission number K071173, sponsored by Ossur Americans (Formerly the Jerome Group). The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-05-25.
- Submission: K071173
- Applicant / Sponsor: Ossur Americans (Formerly the Jerome Group)
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5960
- Decision date: 2007-05-25
Classification & Regulation
This clearance is catalogued under FDA product code HAX and 21 CFR 882.5960, within the Neurology review panel as a Class II device.