Clearance Summary
FISK ARM SUPPORT received FDA 510(k) clearance under submission number K931876, sponsored by Vvortex International Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1993-09-09.
- Submission: K931876
- Applicant / Sponsor: Vvortex International Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1993-09-09
Classification & Regulation
This clearance is catalogued under FDA product code FWW and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.