FDA Registration
Active
🇺🇸 United States
Hydro Putty
Reg #: 3010473074
·
FEI: 3010473074
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WHK BIOSYSTEMS, LLC
- Registration Number
- 3010473074
- FEI Number
- 3010473074
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11345 53rd St N
- City
- Clearwater
- State
- FL
- ZIP
- 33760
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231716
Owner / Operator
- Firm Name
- WHK BioSystems, LLC / Bergman
- Operator Number
- 10045062
- Address
- 11345 53rd Street North
- City
- Clearwater
- State
- FL
- Postal Code
- 33760
- Country
- US
- Correspondent
- Victoria Bergman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-02-12 |
Proprietary Names
Hydro Putty
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)