FDA Registration
Active
🇺🇸 United States
PEPIN MFG., INC.
Reg #: 2132556
·
FEI: 1000221051
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- PEPIN MFG., INC.
- Registration Number
- 2132556
- FEI Number
- 1000221051
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1875 HWY 61 SOUTH
- City
- LAKE CITY
- State
- MN
- ZIP
- 55041
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070807
Owner / Operator
- Firm Name
- PEPIN MFG., INC.
- Operator Number
- 9007792
- Address
- 1875 HWY 61 SOUTH, --
- City
- Lake City
- State
- MN
- Postal Code
- 55041
- Country
- US
- Correspondent
- Melissa - Ryan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2015-09-23 |
| Topical Approximation System | MZR | Class 1 | General Hospital | No | 2023-02-03 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2015-09-23 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2023-03-13 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2007-08-10 |
| System, Skin Closure | MKY | Class 1 | General, Plastic Surgery | No | 2023-02-03 |
Proprietary Names
DuraFuse
CUTANEOUS ELECTROTHERAPY
AdvanTrode®
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device