Clearance Summary
MERTEX-PLUS O.R./SURGEONS GOWN received FDA 510(k) clearance under submission number K953251, sponsored by Mercana Industries , Ltd.. 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 1995-09-05.
- Submission: K953251
- Applicant / Sponsor: Mercana Industries , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1995-09-05
Classification & Regulation
This clearance is catalogued under FDA product code FYA and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.