Clearance Summary
DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 received FDA 510(k) clearance under submission number K061864, sponsored by Dukal 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 2006-09-15.
- Submission: K061864
- Applicant / Sponsor: Dukal Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2006-09-15
Classification & Regulation
This clearance is catalogued under FDA product code FXX and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.