FDA Registration
Active
🇺🇸 United States
MTS300 Multiple Tray Sterilization System
Reg #: 3009545593
·
FEI: 3009545593
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FCM SMART CENTER GROUP
- Registration Number
- 3009545593
- FEI Number
- 3009545593
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1515 Gunn Hwy
- City
- Odessa
- State
- FL
- ZIP
- 33556
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152014
Owner / Operator
- Firm Name
- Caribbean Custom Mold Inc
- Operator Number
- 10047366
- Address
- Zona Franca Las Americas, Aut Las Americas KM.22
- City
- Santo Domingo
- State
- DO-32
- Postal Code
- 11606
- Country
- DO
- Correspondent
- Randolph Geronimo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2024-10-23 |
Proprietary Names
MTS300 Multiple Tray Sterilization System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)