FDA Registration
Active
🇺🇸 United States
CoolSeal Trinity
Reg #: 3010377594
·
FEI: 3010377594
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BOLDER SURGICAL, LLC
- Registration Number
- 3010377594
- FEI Number
- 3010377594
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 331 S. 104th Street, Suite 200
- City
- LOUISVILLE
- State
- CO
- ZIP
- 80027
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211579
Owner / Operator
- Firm Name
- Bolder Surgical
- Operator Number
- 10044568
- Address
- 331 South 104th Street, Suite 200
- City
- Louisville
- State
- CO
- Postal Code
- 80027
- Country
- US
- Correspondent
- Nick Wong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-09-09 |
Proprietary Names
CoolSeal Trinity
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility