FDA Registration
Active
🇺🇸 United States
OTOSCOPE AND ACCESSORIES
Reg #: 2243757
·
FEI: 2243757
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ACTEON, INC.
- Registration Number
- 2243757
- FEI Number
- 2243757
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 124 Gaither Dr Ste 140
- City
- Mount Laurel
- State
- NJ
- ZIP
- 08054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K945264
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2006-10-18 |
Proprietary Names
OTOSCOPE AND ACCESSORIES
Establishment Types
Repack or Relabel Medical Device