FDA Registration
Active
🇺🇸 United States
Glean Urodynamics System
Reg #: 3014644251
·
FEI: 3014644251
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BLUR PRODUCT DEVELOPMENT
- Registration Number
- 3014644251
- FEI Number
- 3014644251
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 260 James Jackson Ave.
- City
- Cary
- State
- NC
- ZIP
- 27513
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243052
Owner / Operator
- Firm Name
- Blur Development Group
- Operator Number
- 10087809
- Address
- 260 James Jackson Ave.
- City
- Cary
- State
- NC
- Postal Code
- 27513
- Country
- US
- Correspondent
- Anthony P Guazzo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2025-06-25 |
Proprietary Names
Glean Urodynamics System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)