FDA Registration
Active
🇺🇸 United States
Single-Use Instrumentation Set & Single-Use Sizer Set
Reg #: 3031343865
·
FEI: 3031343865
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SWAMI MEDICAL
- Registration Number
- 3031343865
- FEI Number
- 3031343865
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2010 Jimmy Durante Blvd, Suite 200
- City
- Del Mar
- State
- CA
- ZIP
- 92014
- Country
- US
Owner / Operator
- Firm Name
- Swami Medical
- Operator Number
- 10090944
- Address
- 2010 Jimmy Durante Blvd, Suite 200
- City
- Del Mar
- State
- CA
- Postal Code
- 92014
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instruments Designed For Press-Fit Osteochondral Implants | QBO | Class 2 | Orthopedic | No | 2024-06-05 |
Proprietary Names
Single-Use Instrumentation Set & Single-Use Sizer Set
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility