FDA Registration
Active
🇺🇸 United States
Guardian Cranial Burr Hole Cover System
Reg #: 1627487
·
FEI: 1627487
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Abbott Medical
- Registration Number
- 1627487
- FEI Number
- 1627487
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6901 Preston Rd
- City
- PLANO
- State
- TX
- ZIP
- 75024
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181382
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2018-08-22 |
Proprietary Names
Guardian Cranial Burr Hole Cover System
Establishment Types
Manufacture Medical Device