FDA Registration
Active
🇺🇸 United States
Epi-Stop Nasal Gel
Reg #: 3015174190
·
FEI: 3015174190
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- BIOMED ENT, INC
- Registration Number
- 3015174190
- FEI Number
- 3015174190
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 250 E Wisconsin Ave Fl 18
- City
- Milwaukee
- State
- WI
- ZIP
- 53202
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230142
Owner / Operator
- Firm Name
- BioMed ENT, Inc
- Operator Number
- 10084500
- Address
- 250 E Wisconsin Avenue, 18th Floor
- City
- Milwaukee
- State
- WI
- Postal Code
- 53202
- Country
- US
- Correspondent
- Tonny Voermans
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2023-11-29 |
Proprietary Names
Epi-Stop Nasal Gel
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198