FDA Registration
Active
🇺🇸 United States
Herbst Sleep Appliance
Reg #: 1316408
·
FEI: 1316408
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Great Lakes Dental Technologies, Ltd.
- Registration Number
- 1316408
- FEI Number
- 1316408
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 200 COOPER AVENUE
- City
- TONAWANDA
- State
- NY
- ZIP
- 14150
- Country
- US
Regulatory Submissions
- 510(k) Number
- K955822
Owner / Operator
- Firm Name
- Great Lakes Dental Technologies, Ltd.
- Operator Number
- 1316408
- Address
- 200 COOPER AVE., --
- City
- Tonawanda
- State
- NY
- Postal Code
- 14150
- Country
- US
- Correspondent
- Joseph Mazurkiewicz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Anti-Snoring | LRK | Class 2 | Dental | No | 2011-02-18 |
Proprietary Names
Herbst Sleep Appliance
Establishment Types
Manufacture Medical Device