FDA Registration
Active
🇺🇸 United States
Sherlock 3CG+ Tip Confirmation System, K180560
Reg #: 3024673
·
FEI: 3024673
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QUALITEL CORPORATION
- Registration Number
- 3024673
- FEI Number
- 3024673
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11831 Beverly Park Road, Bldg A
- City
- Everett
- State
- WA
- ZIP
- 98204
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180560
Owner / Operator
- Firm Name
- QUALITEL CORPORATION
- Operator Number
- 9000166
- Address
- 11831 Beverly Park Road, Bldg. A, --
- City
- Everett
- State
- WA
- Postal Code
- 98204
- Country
- US
- Correspondent
- Reese Hughey
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2022-01-05 |
Proprietary Names
Sherlock 3CG+ Tip Confirmation System, K180560
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)