Clearance Summary
Skypro, SP01 Mask received FDA 510(k) clearance under submission number K152197, sponsored by Skypro Medical Supplies Company. 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 2016-08-26.
- Submission: K152197
- Applicant / Sponsor: Skypro Medical Supplies Company
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2016-08-26
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.