Clearance Summary
PROCEDURE MASKS: PM4-301 AND PM4-304 received FDA 510(k) clearance under submission number K011789, sponsored by Primeline Medical Products, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2001-06-22.
- Submission: K011789
- Applicant / Sponsor: Primeline Medical Products, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2001-06-22
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.