FDA Registration
Active
🇨🇦 Canada
GEORGE COUREY INC
Reg #: 3015068387
·
FEI: 3015068387
·
Expires 2026
Products
9
Proprietary Names
1
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- GEORGE COUREY INC
- Registration Number
- 3015068387
- FEI Number
- 3015068387
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6220 Ernest Cormier
- City
- Montreal Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K250321
Owner / Operator
- Firm Name
- George Courey Inc
- Operator Number
- 10087297
- Address
- 6620 Ernest-Cormier
- City
- Montreal
- State
- Quebec
- Postal Code
- H7C 2T5
- Country
- CA
US Agent
- Business Name
- George Courey Inc
- Contact Name
- Robert Horowitz
- Address
- 10594 Florence Jean Dr
- City
- Jacksonville
- State
- FL
- ZIP
- 32257
- Country
- US
- [email protected]
- Phone
- 201 2471328
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2023-02-09 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2024-02-22 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2023-11-30 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2025-08-18 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2024-02-19 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2024-11-20 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2024-02-19 |
| Cover, Mattress (Medical Purposes) | FMW | Class 1 | General Hospital | No | 2023-02-28 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2024-04-17 |
Proprietary Names
George Courey
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility