510(k) K170848
K170848 is an FDA 510(k) premarket notification submitted by Nasaleze International, Ltd. for the device "Alzair Allergy Blocker". The FDA issued a decision of Substantially Equivalent on June 14, 2017. The device falls under product code NUP (Cream, Nasal, Topical, Mechanical Allergen Particle Barrier), a Class II device regulated under 21 CFR 880.5045. Nasaleze International, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2017
- Date Received
- March 21, 2017
- 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.