FDA Registration
Active
🇺🇸 United States
Lake Region Medical
Reg #: 2126666
·
FEI: 2126666
·
Expires 2025
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Lake Region Medical
- Registration Number
- 2126666
- FEI Number
- 2126666
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 340 Lake Hazeltine Dr
- City
- CHASKA
- State
- MN
- ZIP
- 55318
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080508
Owner / Operator
- Firm Name
- Lake Region Medical
- Operator Number
- 2126666
- Address
- 340 Lake Hazeltine Drive, --
- City
- Chaska
- State
- MN
- Postal Code
- 55318
- Country
- US
- Correspondent
- Paul - Trnka
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2008-11-03 |
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | GCA | Class 2 | Gastroenterology, Urology | No | 2008-11-03 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2008-11-03 |
| Accessories, Catheter, G-U | KNY | Class 2 | Gastroenterology, Urology | No | 2008-11-03 |
| Stylet For Catheter, Gastro-Urology | EZB | Class 1 | Gastroenterology, Urology | No | 2008-11-03 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2008-11-03 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2008-11-03 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)