FDA Registration
Active
🇺🇸 United States
PinXel-RF
Reg #: 1064858
·
FEI: 3008397795
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ANDERSEN SCIENTIFIC, INC.
- Registration Number
- 1064858
- FEI Number
- 3008397795
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1001 Aviation Parkway, Suite 600
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180654
Owner / Operator
- Firm Name
- ANDERSEN SCIENTIFIC, INC.
- Operator Number
- 9034670
- Address
- 1001 Aviation Parkway, Suite 600
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- DARYL - WOODMAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Skin Resurfacing Rf Applicator | OUH | Class 2 | General, Plastic Surgery | No | 2018-11-28 |
Proprietary Names
PinXel-RF
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)