FDA Registration
Active
🇺🇸 United States
OMS2380 Surgical Microscope
Reg #: 2127132
·
FEI: 2127132
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ENOVA ILLUMINATION, INC
- Registration Number
- 2127132
- FEI Number
- 2127132
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6305 Sandburg Rd., Suite 100
- City
- Minneapolis
- State
- MN
- ZIP
- 55427
- Country
- US
Owner / Operator
- Firm Name
- Enova Illumination Inc.
- Operator Number
- 2127132
- Address
- 6305 Sandburg Rd, Suite 100
- City
- Minneapolis
- State
- MN
- Postal Code
- 55427
- Country
- US
- Correspondent
- Jeremy H Ward
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2020-09-08 |
Proprietary Names
OMS2380 Surgical Microscope
OMS3200 Surgical Microscope
OMS2360 Surgical Microscope
OMS3200 R2 Surgical Microscope
OMS3200Pro Surgical Microscope
OMS1950 Surgical Microscope
OMS2380 R2 Surgical Microscope
OMS2350 Surgical Microscope
OMS3500 Surgical Microscope
Establishment Types
Complaint File Establishment per 21 CFR 820.198