Clearance Summary
CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR received FDA 510(k) clearance under submission number K082258, sponsored by Crosstex International. 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 2008-10-16.
- Submission: K082258
- Applicant / Sponsor: Crosstex International
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2008-10-16
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.