FDA Registration
Active
🇺🇸 United States
Bakri Postpartum Balloon
Reg #: 1825146
·
FEI: 1825146
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cook Incorporated
- Registration Number
- 1825146
- FEI Number
- 1825146
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1100 W Morgan St
- City
- Spencer
- State
- IN
- ZIP
- 47460
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170622
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 |
|---|---|---|---|---|---|
| Intrauterine Tamponade Balloon | OQY | Class 2 | Obstetrics/Gynecology | No | 2017-11-21 |
Proprietary Names
Bakri Postpartum Balloon
Establishment Types
Manufacture Medical Device