FDA Registration
Active
🇺🇸 United States
Precision Edge Surgical Products, LLC
Reg #: 3026576110
·
FEI: 3026576110
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Precision Edge Surgical Products, LLC
- Registration Number
- 3026576110
- FEI Number
- 3026576110
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1910 N. Wayne Street
- City
- Angola
- State
- IN
- ZIP
- 46703
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230202
Owner / Operator
- Firm Name
- Precision Edge Surgical Products Company
- Operator Number
- 10042577
- Address
- 415 West 12th Avenue
- City
- Sault Sainte Marie
- State
- MI
- Postal Code
- 49783
- Country
- US
- Correspondent
- Angela Gorsuch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-09-05 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)