FDA Registration
Active
🇫🇷 France
Scaler Ultrasonic Device
Reg #: 8044015
·
FEI: 3004536551
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SATELEC-ACTEON GROUP
- Registration Number
- 8044015
- FEI Number
- 3004536551
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Z.I. DU PHARE, 17, AVENUE GUSTAVE EIFFEL
- City
- MERIGNAC Gironde
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K972026
Owner / Operator
- Firm Name
- SATELEC-ACTEON GROUP
- Operator Number
- 9004992
- Address
- 124 Gaither Drive, Suite 140
- City
- Mount Laurel
- State
- NJ
- Postal Code
- 08054
- Country
- US
- Correspondent
- Noelle Zuccarello
US Agent
- Business Name
- SATELEC - ACTEON, INC.
- Contact Name
- Noelle Zuccarello
- Address
- 124 GAITHER DR., SUITE 140
- City
- MOUNT LAUREL
- State
- NJ
- ZIP
- 08054
- Country
- US
- [email protected]
- Phone
- 856 2229988 ext. 280
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2008-02-15 |
Proprietary Names
Scaler Ultrasonic Device
Establishment Types
Manufacture Medical Device