Clearance Summary
NASAL EASE ALLERGY BLOCKER received FDA 510(k) clearance under submission number K132520, sponsored by Hi-Tech Pharmacal, Inc.. 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 2013-12-31.
- Submission: K132520
- Applicant / Sponsor: Hi-Tech Pharmacal, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5045
- Decision date: 2013-12-31
Classification & Regulation
This clearance is catalogued under FDA product code NUP and 21 CFR 880.5045, within the General Hospital review panel as a Class II device.