Clearance Summary
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) received FDA 510(k) clearance under submission number K190308, sponsored by Amd Medicom, 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 2019-09-17.
- Submission: K190308
- Applicant / Sponsor: Amd Medicom, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2019-09-17
Classification & Regulation
This clearance is catalogued under FDA product code OXZ and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.