Clearance Summary
MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) received FDA 510(k) clearance under submission number K093179, sponsored by H&H Research Company. 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 2010-07-14.
- Submission: K093179
- Applicant / Sponsor: H&H Research Company
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2010-07-14
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.