FDA Registration
Active
🇺🇸 United States
Park's Pectus System
Reg #: 3010509633
·
FEI: 3010509633
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SOLCO BIOMEDICAL CORP.
- Registration Number
- 3010509633
- FEI Number
- 3010509633
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4100 Midway Rd Ste 1130
- City
- Carrollton
- State
- TX
- ZIP
- 75007
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191057
Owner / Operator
- Firm Name
- SOLCO BIOMEDICAL CORPORATION
- Operator Number
- 10045137
- Address
- 4100 Midway Rd. Ste 1130
- City
- Carrollton
- State
- TX
- Postal Code
- 75007
- Country
- US
- Correspondent
- MIN SEOK SEO
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-02-01 |
Proprietary Names
Park's Pectus System
Establishment Types
Repack or Relabel Medical Device