510(k) K053625
K053625 is an FDA 510(k) premarket notification submitted by Trutek Corp for the device "NASALGUARD". The FDA issued a decision of Substantially Equivalent on Feb 22, 2006. The device falls under product code NUP (Cream, Nasal, Topical, Mechanical Allergen Particle Barrier), a Class II device regulated under 21 CFR 880.5045. Trutek Corp has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 22, 2006
- Date Received
- Dec 28, 2005
- 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
- 510(k)
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.