FDA Registration
Active
🇺🇸 United States
GLYDE
Reg #: 3007671445
·
FEI: 3007671445
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SOOKA INC.
- Registration Number
- 3007671445
- FEI Number
- 3007671445
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 514 Daniels Street, Ste 109
- City
- Raleigh
- State
- NC
- ZIP
- 27605
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012964
Owner / Operator
- Firm Name
- Sooka Inc.
- Operator Number
- 10033614
- Address
- 514 Daniels Street, Unit 109
- City
- Raleigh
- State
- NC
- Postal Code
- 27605
- Country
- US
- Correspondent
- Kimberly Ardwell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2010-09-03 |
Proprietary Names
GLYDE
Establishment Types
Repack or Relabel Medical Device