FDA Registration
Active
🇺🇸 United States
Atlantis TPC
Reg #: 1065845
·
FEI: 3003040707
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- X-CEL SPECIALTY CONTACTS
- Registration Number
- 1065845
- FEI Number
- 3003040707
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2775 Premiere Pkwy Ste 600
- City
- DULUTH
- State
- GA
- ZIP
- 30097
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171404
Owner / Operator
- Firm Name
- Walman Optical
- Operator Number
- 2125182
- Address
- 2775 Premiere Parkway Ste 600
- City
- Duluth
- State
- GA
- Postal Code
- 30097
- Country
- US
- Correspondent
- Hue N Tang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | Class 2 | Ophthalmic | No | 2021-09-23 |
Proprietary Names
Atlantis TPC
Atlantis FT
Atlantis LD
Pinnacle LD
Spherical
Pinnacle
Atlantis MF
Pinnacle IC
Apex
Atlantis 3D
Titan LD
Starlens
Atlantis
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)