FDA Registration
Active
🇺🇸 United States
extriCARE 3000 Negative Pressure Wound Therapy System (EC3000)
Reg #: 3021767551
·
FEI: 3021767551
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ALLEVA MEDICAL DEVICES
- Registration Number
- 3021767551
- FEI Number
- 3021767551
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1050 W. Central Avenue, Unit B
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221223
Owner / Operator
- Firm Name
- Alleva Medical Devices
- Operator Number
- 10084505
- Address
- 1050 W. Central Avenue, Unit B
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
- Correspondent
- Max Choi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | Class 2 | General, Plastic Surgery | No | 2023-02-10 |
Proprietary Names
extriCARE 3000 Negative Pressure Wound Therapy System (EC3000)
ExtriCARE 3000 Negative Pressure Wound Therapy System 400cc Canister (EC3000-400CC)
ExtrICARE 3000 Negative Pressure Wound Therapy System 100cc Canister (EC3000-100C)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility