FDA Registration
Active
🇺🇸 United States
GENERAL SCIENTIFIC CORP.
Reg #: 1834177
·
FEI: 1000160378
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- GENERAL SCIENTIFIC CORP.
- Registration Number
- 1834177
- FEI Number
- 1000160378
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 77 ENTERPRISE DR.
- City
- ANN ARBOR
- State
- MI
- ZIP
- 48103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K934494
Owner / Operator
- Firm Name
- General Scientific Corporation
- Operator Number
- 9009191
- Address
- 77 Enterprise Dr, --
- City
- Ann Arbor
- State
- MI
- Postal Code
- 48103
- Country
- US
- Correspondent
- Carrie A Good
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spectacle, Operating (Loupe), Ophthalmic | HOH | Class 1 | Ophthalmic | No | 2008-06-24 |
| Camera, Cine, Surgical, With Audio | FWI | Class 1 | General, Plastic Surgery | No | 2024-04-16 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2021-06-22 |
Proprietary Names
SurgiTel
SurgiCam Pro
SurgiCam HD
SurgiCam
Establishment Types
Manufacture Medical Device