FDA Registration
Active
🇺🇸 United States
SRT-100+
Reg #: 3030230020
·
FEI: 3030230020
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KOPLAK CORP
- Registration Number
- 3030230020
- FEI Number
- 3030230020
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 775 Shotgun Rd
- City
- Sunrise
- State
- FL
- ZIP
- 33326
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173425
Owner / Operator
- Firm Name
- Koplak Corp
- Operator Number
- 10089438
- Address
- 775 Shotgun Rd
- City
- Sunrise
- State
- FL
- Postal Code
- 33326
- Country
- US
- Correspondent
- Mariano Martinez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Therapeutic, X-Ray | JAD | Class 2 | Radiology | No | 2023-12-07 |
Proprietary Names
SRT-100+
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)