FDA Registration
Active
🇦🇺 Australia
Herbst Telescopic Classic
Reg #: 3005343849
·
FEI: 3005343849
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SOMNOMED, LTD.
- Registration Number
- 3005343849
- FEI Number
- 3005343849
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LEVEL 3, 20 CLARKE ST.
- City
- CROWS NEST New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K130558
Owner / Operator
- Firm Name
- SOMNOMED INC.
- Operator Number
- 9071127
- Address
- 6513 Windcrest Drive, Suite #100
- City
- Plano
- State
- TX
- Postal Code
- 75024
- Country
- US
- Correspondent
- Mary Kennell
US Agent
- Business Name
- SomnoMed
- Contact Name
- Matthew Baris
- Address
- 6513 Windcrest Dr Ste 100
- City
- Plano
- State
- TX
- ZIP
- 75024
- Country
- US
- [email protected]
- Phone
- 281 5152925
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2013-05-21 |
Proprietary Names
Herbst Telescopic Classic
Herbst Advance Flex
Herbst Telescopic Flex
Herbst Shim Flex
Herbst Shim Classic
Herbst Advance Classic
SomnoDent Herbst Advance Elite
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility