FDA Registration
Active
🇺🇸 United States
AMM
Reg #: 3023851864
·
FEI: 3023851864
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PALMETTO HOLDINGS HK LLC
- Registration Number
- 3023851864
- FEI Number
- 3023851864
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1818 Wyngate Dr
- City
- Troy
- State
- MI
- ZIP
- 48098
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202003
Owner / Operator
- Firm Name
- Palmetto Holdings HK LLC
- Operator Number
- 10090070
- Address
- 1818 Wyngate Dr
- City
- Troy
- State
- MI
- Postal Code
- 48098
- Country
- US
- Correspondent
- Andrew Kotsovos
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-06-10 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-06-10 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-06-10 |
Proprietary Names
AMM
Establishment Types
Complaint File Establishment per 21 CFR 820.198