FDA Registration
Active
🇺🇸 United States
PNEO, LLC
Reg #: 3011418975
·
FEI: 3011418975
·
Expires 2026
Products
6
Proprietary Names
4
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- PNEO, LLC
- Registration Number
- 3011418975
- FEI Number
- 3011418975
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 204 Cardinal Drive
- City
- Denton
- State
- TX
- ZIP
- 76209
- Country
- US
Regulatory Submissions
- 510(k) Number
- K082762
Owner / Operator
- Firm Name
- pNeo, LLC
- Operator Number
- 10048567
- Address
- 204 Cardinal Drive
- City
- Denton
- State
- TX
- Postal Code
- 76209
- Country
- US
- Correspondent
- Charlotte Wenham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2015-01-27 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2025-12-23 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2024-12-26 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2015-01-27 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2016-08-25 |
| Nasal Spray, Ent Delivery | KCO | Class 1 | Ear, Nose, Throat | No | 2024-12-26 |
Proprietary Names
Shusher Care
Shusher Care Atomizing Nebulizer
Shusher Care Atomizer
Oto-Tip
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility