FDA Registration
Active
🇺🇸 United States
EG2
Reg #: 1319182
·
FEI: 1319182
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- GLOTTAL ENT., INC.
- Registration Number
- 1319182
- FEI Number
- 1319182
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1201 E. FAYETTE ST.
- City
- SYRACUSE
- State
- NY
- ZIP
- 13210
- Country
- US
Regulatory Submissions
- 510(k) Number
- K901609
Owner / Operator
- Firm Name
- GLOTTAL ENTERPRISES, INC.
- Operator Number
- 1319182
- Address
- 1201 E. FAYETTE ST., SUITE #15
- City
- Syracuse
- State
- NY
- Postal Code
- 13210
- Country
- US
- Correspondent
- MARTIN - ROTHENBERG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electroglottograph | KLX | Class 2 | Ear, Nose, Throat | No | 1992-07-17 |
Proprietary Names
EG2
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device