FDA Registration
Active
🇺🇸 United States
MACKAY MANUFACTURING, INC.
Reg #: 3003935342
·
FEI: 3003935342
·
Expires 2025
Products
9
Proprietary Names
0
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- MACKAY MANUFACTURING, INC.
- Registration Number
- 3003935342
- FEI Number
- 3003935342
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10011 E Montgomery Dr
- City
- Spokane Valley
- State
- WA
- ZIP
- 99206
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210574
Owner / Operator
- Firm Name
- MacKay Manufacturing, Inc.
- Operator Number
- 10042071
- Address
- 10011 E. Montgomery Drive
- City
- Spokane Valley
- State
- WA
- Postal Code
- 99206
- Country
- US
- Correspondent
- Don Ludington
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-01-22 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-22 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-01-22 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2025-01-22 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-01-22 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-01-22 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-01-22 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-22 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-01-22 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)