Clearance Summary
STERILE INSTRUMENT DRAPE received FDA 510(k) clearance under submission number K902763, sponsored by North American Sterilization & Packaging Co.. 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 1990-09-20.
- Submission: K902763
- Applicant / Sponsor: North American Sterilization & Packaging Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1990-09-20
Classification & Regulation
This clearance is catalogued under FDA product code HMW and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.