FDA Registration
Active
🇰🇷 South Korea
Fluorescence Imaging Kit
Reg #: 3017619652
·
FEI: 3017619652
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Chun Ahn Logistics
- Registration Number
- 3017619652
- FEI Number
- 3017619652
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3F,15 Beon-Gil 54, Hagal-RO Bora-Dong
- City
- Guiheung-GU Yongin-Si, Kyunggi-DO Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K141077
Owner / Operator
- Firm Name
- Intuitive Surgical, Inc.
- Operator Number
- 9028901
- Address
- 1266 Kifer Road, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94086
- Country
- US
- Correspondent
- Mario Lowe
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2020-11-05 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2020-11-05 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-11-05 |
Proprietary Names
Fluorescence Imaging Kit
8mm 30 degree endoscope
8mm 0 degree endoscope
Establishment Types
Export Device to the United States But Perform No Other Operation on Device