Clearance Summary
HIGH FILTRATION ISO-MASK received FDA 510(k) clearance under submission number K831148, sponsored by Tecnol New Jersey Wound Care, Inc.. 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 1984-07-17.
- Submission: K831148
- Applicant / Sponsor: Tecnol New Jersey Wound Care, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1984-07-17
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.