Clearance Summary
MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 received FDA 510(k) clearance under submission number K102173, sponsored by Moldex/Metric, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2010-09-13.
- Submission: K102173
- Applicant / Sponsor: Moldex/Metric, Inc.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2010-09-13
Classification & Regulation
This clearance is catalogued under FDA product code MSH and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.