Clearance Summary
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR received FDA 510(k) clearance under submission number K021546, sponsored by Creative Contract (M) Sdn Bhd. 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 2003-03-05.
- Submission: K021546
- Applicant / Sponsor: Creative Contract (M) Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2003-03-05
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.