FDA Registration
Active
🇺🇸 United States
Chemo Mouthpiece
Reg #: 3015177652
·
FEI: 3015177652
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ChemoMouthpiece, LLC D/B/A Ice Cold Mouthpiece
- Registration Number
- 3015177652
- FEI Number
- 3015177652
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3411 Silverside Rd
- City
- Wilmington
- State
- DE
- ZIP
- 19810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232917
Owner / Operator
- Firm Name
- Chemo Mouthpiece, LLC D/B/A Ice Cold Mouthpiece
- Operator Number
- 10058983
- Address
- 3411 Silverside Road
- City
- Wilmington
- State
- DE
- Postal Code
- 19810
- Country
- US
- Correspondent
- David Yoskowitz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intraoral Cooling Device | QUA | Class 2 | Dental | No | 2024-03-07 |
Proprietary Names
Chemo Mouthpiece
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198