FDA Registration
Active
🇺🇸 United States
HotHands Therapy Warming Earplugs
Reg #: 3003079019
·
FEI: 3003079019
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- KOBAYASHI AMERICA MANUFACTURING, LLC
- Registration Number
- 3003079019
- FEI Number
- 3003079019
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 245 KRAFT DR
- City
- Dalton
- State
- GA
- ZIP
- 30721
- Country
- US
Owner / Operator
- Firm Name
- KOBAYASHI AMERICA MANUFACTURING, LLC
- Operator Number
- 10049550
- Address
- 245 KRAFT DRIVE
- City
- Dalton
- State
- GA
- Postal Code
- 30721
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2023-08-02 |
Proprietary Names
HotHands Therapy Warming Earplugs
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility