FDA Registration
Active
🇲🇽 Mexico
Disposable Speculum Kit for Hydro-San Plus
Reg #: 3022964615
·
FEI: 3022964615
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Life Outcomes Javid de Mexico
- Registration Number
- 3022964615
- FEI Number
- 3022964615
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- S de RL de CV Blvd. Luis Donaldo Colosio 2880-D, Parque industrial de Nogales
- City
- Nogales Sonora
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K891585
Owner / Operator
- Firm Name
- Life Outcomes, LLC
- Operator Number
- 10085285
- Address
- 88 Inverness Cir East, Suite E-102
- City
- Englewood
- State
- CO
- Postal Code
- 80112
- Country
- US
- Correspondent
- Sardar Mostofa
US Agent
- Business Name
- LIFE OUTCOMES, LLC
- Contact Name
- Sardar Mostofa
- Address
- 88 Inverness Cir East, Suite E-102
- City
- Englewood
- State
- CO
- ZIP
- 80112
- Country
- US
- [email protected]
- Phone
- 520 3120668
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colonic Irrigation System | KPL | Class 2 | Gastroenterology, Urology | No | 2024-09-03 |
Proprietary Names
Disposable Speculum Kit for Hydro-San Plus
Establishment Types
Repack or Relabel Medical Device