← FDA Medical Device Classifications
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
NUP · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5045
Classification
- FDA Product Code
NUP- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 880.5045
- Review panel
- EN
- Medical specialty
- General Hospital
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
Market data
- Cleared 510(k) submissions
- 8
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown