FDA Registration
Active
🇺🇸 United States
Klear Vision Surgical Face Masks - ASTM F2100
Reg #: 2518423
·
FEI: 2518423
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- BERKLEY MEDICAL RESOURCES, INC.
- Registration Number
- 2518423
- FEI Number
- 2518423
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 49 Virginia Ave
- City
- UNIONTOWN
- State
- PA
- ZIP
- 15401
- Country
- US
Regulatory Submissions
- 510(k) Number
- K962286
Owner / Operator
- Firm Name
- BERKLEY MEDICAL RESOURCES, INC.
- Operator Number
- 2518423
- Address
- 49 VIRGINIA AVE., --
- City
- Uniontown
- State
- PA
- Postal Code
- 15401
- Country
- US
- Correspondent
- Domenic A Tommarello
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2007-10-28 |
Proprietary Names
Klear Vision Surgical Face Masks - ASTM F2100
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device