Clearance Summary
AQUAPLAST TIE DOWN DRESSING received FDA 510(k) clearance under submission number K943871, sponsored by Wfr/Aquaplast Corp.. 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 1994-09-30.
- Submission: K943871
- Applicant / Sponsor: Wfr/Aquaplast Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4014
- Decision date: 1994-09-30
Classification & Regulation
This clearance is catalogued under FDA product code LZM and 21 CFR 878.4014, within the General, Plastic Surgery review panel as a Class I device.