FDA Registration
Active
🇺🇸 United States
Fluorescence Imaging For Breast Cancer Detection - Lumicell Direct Visualization System (DVS)
Reg #: 1221051
·
FEI: 1221051
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- J-PAC, LLC.
- Registration Number
- 1221051
- FEI Number
- 1221051
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 25 CENTRE RD.
- City
- SOMERSWORTH
- State
- NH
- ZIP
- 03878
- Country
- US
Regulatory Submissions
- PMA Number
- P230014
Owner / Operator
- Firm Name
- J-Pac Medical
- Operator Number
- 10034516
- Address
- 25 Centre Rd
- City
- Somersworth
- State
- NH
- Postal Code
- 03878
- Country
- US
- Correspondent
- Prashanth Gopal
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fluorescence Imaging For Breast Cancer Detection | SAW | Class 3 | Unknown | No | 2024-12-09 |
Proprietary Names
Fluorescence Imaging For Breast Cancer Detection - Lumicell Direct Visualization System (DVS)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)