FDA Registration
Active
🇺🇸 United States
Liver Access and Biopsy Needle
Reg #: 1000393132
·
FEI: 1000393132
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COOK INCORPORATED
- Registration Number
- 1000393132
- FEI Number
- 1000393132
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6300 N. MATTHEWS DR.
- City
- ELLETTSVILLE
- State
- IN
- ZIP
- 47429
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171853
Owner / Operator
- Firm Name
- COOK, INC.
- Operator Number
- 1820334
- Address
- 750 DANIELS WAY
- City
- Bloomington
- State
- IN
- Postal Code
- 47404
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2019-01-16 |
Proprietary Names
Liver Access and Biopsy Needle
Liver Access and Biopsy Needle Set
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)