FDA Registration
Active
🇺🇸 United States
System, Radiation Therapy, Charged-Particle, Medical - McLaren Proton Therapy System
Reg #: 3015178562
·
FEI: 3015178562
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- McLaren Health Care
- Registration Number
- 3015178562
- FEI Number
- 3015178562
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- G-3235 Beecher Rd., Suite B
- City
- Flint
- State
- MI
- ZIP
- 48532
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160063
Owner / Operator
- Firm Name
- McLaren Healthcare
- Operator Number
- 10089472
- Address
- 4100 Beecher Rd.
- City
- Flint
- State
- MI
- Postal Code
- 48532
- Country
- US
- Correspondent
- Kim Chaperon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2023-12-11 |
Proprietary Names
System, Radiation Therapy, Charged-Particle, Medical - McLaren Proton Therapy System
Establishment Types
Manufacture Medical Device