Clearance Summary
IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL received FDA 510(k) clearance under submission number K964113, sponsored by M-Pact Worldwide Management 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 1996-11-07.
- Submission: K964113
- Applicant / Sponsor: M-Pact Worldwide Management Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4100
- Decision date: 1996-11-07
Classification & Regulation
This clearance is catalogued under FDA product code EMX and 21 CFR 874.4100, within the Ear, Nose, Throat review panel as a Class I device.