Clearance Summary
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM received FDA 510(k) clearance under submission number K992702, sponsored by Allergy Direct. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1999-11-08.
- Submission: K992702
- Applicant / Sponsor: Allergy Direct
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6190
- Decision date: 1999-11-08
Classification & Regulation
This clearance is catalogued under FDA product code FMW and 21 CFR 880.6190, within the General Hospital review panel as a Class I device.