FDA Registration
Active
🇺🇸 United States
11400-210/350-150, ICIA-210/350-150, Intacs Corneal Implants, Asymmetric 0.210mm/0.350mm
Reg #: 2953726
·
FEI: 3000309468
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ADDITION TECHNOLOGY, INC.
- Registration Number
- 2953726
- FEI Number
- 3000309468
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 820 Oak Creek Dr
- City
- Lombard
- State
- IL
- ZIP
- 60148
- Country
- US
Regulatory Submissions
- PMA Number
- H040002
Owner / Operator
- Firm Name
- Addition Technology
- Operator Number
- 9099993
- Address
- 820 Oak Creek Drive
- City
- Lombard
- State
- IL
- Postal Code
- 60148
- Country
- US
- Correspondent
- Daniel Salazar
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Corneal, Refractive | LQE | Class 3 | Unknown | No | 2014-12-12 |
Proprietary Names
11400-210/350-150, ICIA-210/350-150, Intacs Corneal Implants, Asymmetric 0.210mm/0.350mm
11600-350-150, ICI-350-150, Intacs Corneal Implants 0.350mm
11400-210/300-150, ICIA-210/300-150, Intacs Corneal Implants, Asymmetric 0.210mm/0.300mm
11600-450-150, ICI-450-150, Intacs Corneal Implants 0.450mm
11600-210-150, ICI-210-150, Intacs Corneal Implants 0.210mm
11400-210/450-150, ICIA-210/450-150, Intacs Corneal Implants, Asymmetric 0.210mm/0.450mm
11400-210/400-150, ICIA-210/400-150, Intacs Corneal Implants, Asymmetric 0.210mm/0.400mm
11600-250-150, ICI-250-150, Intacs Corneal Implants 0.250mm
INTACS
11600-400-150, ICI-400-150, Intacs Corneal Implants 0.400mm
11600-300-150, ICI-300-150, Intacs Corneal Implants 0.300mm
Establishment Types
Manufacture Medical Device