FDA Registration
Active
🇺🇸 United States
DuraFlex CAD disc
Reg #: 3003928050
·
FEI: 3003928050
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MYERSON LLC
- Registration Number
- 3003928050
- FEI Number
- 3003928050
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5106 N RAVENSWOOD AVE
- City
- Chicago
- State
- IL
- ZIP
- 60640
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063626
Owner / Operator
- Firm Name
- Myerson LLC
- Operator Number
- 10029226
- Address
- 5106 N Ravenswood Ave, chicago
- City
- Chicago
- State
- IL
- Postal Code
- 60640
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2019-12-06 |
Proprietary Names
DuraFlex CAD disc
VisiClear CAD disc
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device