FDA Registration
Active
🇺🇸 United States
DigniCap Delta Scalp Cooling System
Reg #: 1648700
·
FEI: 3000204260
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- THERMOTEK, INC.
- Registration Number
- 1648700
- FEI Number
- 3000204260
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1200 LAKESIDE PKWY STE 200
- City
- Flower Mound
- State
- TX
- ZIP
- 75028
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191166
Owner / Operator
- Firm Name
- THERMOTEK, INC.
- Operator Number
- 9016830
- Address
- 1200 Lakeside Parkway #200, --
- City
- Flowermound
- State
- TX
- Postal Code
- 75028
- Country
- US
- Correspondent
- Sara - Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scalp Cooling System | PMC | Class 2 | General, Plastic Surgery | No | 2019-08-23 |
Proprietary Names
DigniCap Delta Scalp Cooling System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)