FDA Registration
Active
🇺🇸 United States
GelPOINT Mini Advanced Access Platform
Reg #: 2027111
·
FEI: 2027111
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- APPLIED MEDICAL RESOURCES CORP.
- Registration Number
- 2027111
- FEI Number
- 2027111
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 22872 AVENIDA EMPRESA
- City
- RSM
- State
- CA
- ZIP
- 92688
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191866
Owner / Operator
- Firm Name
- APPLIED MEDICAL RESOURCES
- Operator Number
- 2027111
- Address
- 22872 AVENIDA EMPRESA, --
- City
- Rancho Santa Margarita
- State
- CA
- Postal Code
- 92688
- Country
- US
- Correspondent
- Leilani - Domingo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-05-11 |
Proprietary Names
GelPOINT Mini Advanced Access Platform
Establishment Types
Manufacture Medical Device