FDA Registration
Active
🇺🇸 United States
CUSTOM MOLDED FOOT ORTHOSIS
Reg #: 3003895329
·
FEI: 3003895329
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SURESTEP, LLC
- Registration Number
- 3003895329
- FEI Number
- 3003895329
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17530 DUGDALE DR
- City
- South Bend
- State
- IN
- ZIP
- 46635
- Country
- US
Owner / Operator
- Firm Name
- SURESTEP, LLC
- Operator Number
- 10028081
- Address
- 17530 DUGDALE DR
- City
- South Bend
- State
- IN
- Postal Code
- 46635
- Country
- US
- Correspondent
- SUZI KLIMEK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2014-03-28 |
Proprietary Names
CUSTOM MOLDED FOOT ORTHOSIS
Surestep
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198