FDA Registration
Active
🇺🇸 United States
PRIMOTEC LLC
Reg #: 3004491043
·
FEI: 3004491043
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRIMOTEC LLC
- Registration Number
- 3004491043
- FEI Number
- 3004491043
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 215 Westport Ave
- City
- Norwalk
- State
- CT
- ZIP
- 06851
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101029
Owner / Operator
- Firm Name
- Primotec LLC
- Operator Number
- 10041713
- Address
- 360 Westport Ave.
- City
- Norwalk
- State
- CT
- Postal Code
- 06851
- Country
- US
- Correspondent
- Christopher Urist
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2018-01-02 |
Establishment Types
Repack or Relabel Medical Device