Clearance Summary
STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP received FDA 510(k) clearance under submission number K950830, sponsored by Avail-Southwest Division. 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 1995-05-03.
- Submission: K950830
- Applicant / Sponsor: Avail-Southwest Division
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1995-05-03
Classification & Regulation
This clearance is catalogued under FDA product code KKX and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.