Clearance Summary
SURGICAL DRAPES, OPHTHALMIN received FDA 510(k) clearance under submission number K854613, sponsored by Charles Atkins & 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 1986-02-13.
- Submission: K854613
- Applicant / Sponsor: Charles Atkins & Co.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 1986-02-13
Classification & Regulation
This clearance is catalogued under FDA product code HMT and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.