FDA Registration
Active
🇺🇸 United States
GOLDMANN APPLANATION TONOMETER - 870 TYPE
Reg #: 3004441848
·
FEI: 3004441848
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- S4OPTIK LLC
- Registration Number
- 3004441848
- FEI Number
- 3004441848
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 11825 Central Parkway
- City
- Jacksonville
- State
- FL
- ZIP
- 32224
- Country
- US
Regulatory Submissions
- 510(k) Number
- K992835
Owner / Operator
- Firm Name
- S4OPTIK LLC
- Operator Number
- 9077083
- Address
- 11825 Central Parkway
- City
- Jacksonville
- State
- FL
- Postal Code
- 32224
- Country
- US
- Correspondent
- Matthew - McKenna
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2015-03-10 |
Proprietary Names
GOLDMANN APPLANATION TONOMETER - 870 TYPE
Z800
Establishment Types
Complaint File Establishment per 21 CFR 820.198