FDA Registration
Active
🇺🇸 United States
Platform Wound Dressing
Reg #: 3015151147
·
FEI: 3015151147
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BOULDER BIOMED LLC
- Registration Number
- 3015151147
- FEI Number
- 3015151147
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5421 Western Avenue
- City
- Boulder
- State
- CO
- ZIP
- 80301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140662
Owner / Operator
- Firm Name
- Boulder BioMed dba Boulder iQ
- Operator Number
- 10058905
- Address
- 5421 Western Avenue
- City
- Boulder
- State
- CO
- Postal Code
- 80301
- Country
- US
- Correspondent
- James F Kasic
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-10-20 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-10-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-10-20 |
Proprietary Names
Platform Wound Dressing
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)