FDA Registration
Active
🇮🇱 Israel
AcuPulse CO2 Laser System
Reg #: 3012911444
·
FEI: 3012911444
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TAMUZ F.T.K. SOLUTIONS
- Registration Number
- 3012911444
- FEI Number
- 3012911444
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kibbutz Yizrael
- City
- Afula Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K212703
Owner / Operator
- Firm Name
- Tamuz F.T.K. Solutions
- Operator Number
- 10060855
- Address
- Kibbutz Yizrael
- City
- Afula
- State
- IL-NOTA
- Postal Code
- 19350
- Country
- IL
- Correspondent
- George Hattub
US Agent
- Business Name
- Medicsense USA
- Contact Name
- George Hattub
- Address
- 291 Hillside Avenue
- City
- Somerset
- State
- MA
- ZIP
- 02726
- Country
- US
- [email protected]
- Phone
- 508 4796116
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-08-08 |
Proprietary Names
AcuPulse CO2 Laser System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)