510(k) K134003
K134003 is an FDA 510(k) premarket notification submitted by Rhinix Aps for the device "RHINIX NASAL FILTER". The FDA issued a decision of Substantially Equivalent on September 4, 2014. The device falls under product code NUP (Cream, Nasal, Topical, Mechanical Allergen Particle Barrier), a Class II device regulated under 21 CFR 880.5045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2014
- Date Received
- December 27, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
- Device Class
- Class II
- Regulation Number
- 880.5045
- Review Panel
- EN
- Submission Type
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.