FDA Registration
Active
🇺🇸 United States
Klarity Bolus
Reg #: 1530561
·
FEI: 3001236129
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- KLARITY MEDICAL PRODUCTS, LLC
- Registration Number
- 1530561
- FEI Number
- 3001236129
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 600 Industrial Pkwy
- City
- Heath
- State
- OH
- ZIP
- 43056
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202747
Owner / Operator
- Firm Name
- KLARITY MEDICAL PRODUCTS, LLC
- Operator Number
- 9031393
- Address
- 600 Industrial Pkwy, --
- City
- Heath
- State
- OH
- Postal Code
- 43056
- Country
- US
- Correspondent
- Michelle P Fritch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2021-06-03 |
Proprietary Names
Klarity Bolus
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device