Clearance Summary
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS received FDA 510(k) clearance under submission number K942158, sponsored by Wfr/Aquaplast Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1994-07-29.
- Submission: K942158
- Applicant / Sponsor: Wfr/Aquaplast Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5800
- Decision date: 1994-07-29
Classification & Regulation
This clearance is catalogued under FDA product code EPP and 21 CFR 874.5800, within the Ear, Nose, Throat review panel as a Class I device.