FDA Registration
Active
🇺🇸 United States
ECT Cotton Bite Block - Size Large
Reg #: 3023869663
·
FEI: 3023869663
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIGMASTIM DOMESTIC LLC
- Registration Number
- 3023869663
- FEI Number
- 3023869663
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 19799 SW 95th Ave. Suite B
- City
- Tualatin
- State
- OR
- ZIP
- 97062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201309
Owner / Operator
- Firm Name
- SigmaStim Domestic LLC
- Operator Number
- 10085899
- Address
- 19799 SW 95th Ave. Suite B
- City
- Tualatin
- State
- OR
- Postal Code
- 97062
- Country
- US
- Correspondent
- Adrian Kettering
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Block, Bite | JXL | Class 2 | Neurology | No | 2023-12-07 |
Proprietary Names
ECT Cotton Bite Block - Size Large
ECT Cotton Bite Block - Size Medium
Establishment Types
Repack or Relabel Medical Device