FDA Registration
Active
🇺🇸 United States
Shikani speaking valves
Reg #: 3008278458
·
FEI: 3008278458
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHIKANI MEDICAL LLC
- Registration Number
- 3008278458
- FEI Number
- 3008278458
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1629 York Road
- City
- Lutherville
- State
- MD
- ZIP
- 21093
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100995
Owner / Operator
- Firm Name
- Shikani Medical LLC (d/b/a The Airway Company)
- Operator Number
- 10031493
- Address
- 1629 York Road
- City
- Lutherville
- State
- MD
- Postal Code
- 21093
- Country
- US
- Correspondent
- Patrick A Shikani
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2010-06-30 |
Proprietary Names
Shikani speaking valves
SSV2 speaking valve
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility