FDA Registration
Active
🇺🇸 United States
Tono Pen Probe Covers
Reg #: 1527493
·
FEI: 1527493
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KILTEX CORP.
- Registration Number
- 1527493
- FEI Number
- 1527493
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2064 KILLIAN ROAD
- City
- Akron
- State
- OH
- ZIP
- 44312
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070534
Owner / Operator
- Firm Name
- KILTEX CORP.
- Operator Number
- 1527493
- Address
- 2064 KILLIAN RD., --
- City
- Akron
- State
- OH
- Postal Code
- 44312
- Country
- US
- Correspondent
- TIMOTHY J KILLIAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2015-06-04 |
Proprietary Names
Tono Pen Probe Covers
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)