FDA Registration
Active
🇲🇽 Mexico
E-Z-EM Enteroclysis Catheter Set, ET 412
Reg #: 3010291427
·
FEI: 3010291427
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AvailMed S.A.De C.V.
- Registration Number
- 3010291427
- FEI Number
- 3010291427
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- C.Industrial Lt.001 Mz.105, No. 20905 Int.A. Col. Cd. Industrial
- City
- Tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K911349
Owner / Operator
- Firm Name
- Flextronics International USA, Inc.
- Operator Number
- 9006592
- Address
- 6201 America Center Drive
- City
- San Jose
- State
- CA
- Postal Code
- 95002
- Country
- US
- Correspondent
- Chad Ashton
US Agent
- Business Name
- FLEXTRONICS INTERNATIONAL USA, INC.
- Contact Name
- Chad Ashton
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- ZIP
- 78759
- Country
- US
- [email protected]
- Phone
- 901 8712423
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Retention Type | EZK | Class 2 | Gastroenterology, Urology | No | 2009-10-22 |
Proprietary Names
E-Z-EM Enteroclysis Catheter Set, ET 412
E-Z-EM Enteroclysis Catheter Set
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)