FDA Registration
Active
🇺🇸 United States
Fluid Resistant Mask with Face Shields
Reg #: 2433012
·
FEI: 2433012
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BUSSE HOSPITAL DISPOSABLES
- Registration Number
- 2433012
- FEI Number
- 2433012
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 75 ARKAY DR.
- City
- HAUPPAUGE
- State
- NY
- ZIP
- 11788
- Country
- US
Regulatory Submissions
- 510(k) Number
- K940720
Owner / Operator
- Firm Name
- ROBERT BUSSE & CO., INC.
- Operator Number
- 2417536
- Address
- 75 ARKAY DR., --
- City
- HAUPPAUGE
- State
- NY
- Postal Code
- 11788
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2013-12-03 |
Proprietary Names
Fluid Resistant Mask with Face Shields
Fluid Resistant Mask
Isolation Mask
Procedural Mask
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device