FDA Registration
Active
🇩🇪 Germany
Suprathel Hand
Reg #: 3007710611
·
FEI: 3007710611
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- POLYMEDICS INNOVATIONS
- Registration Number
- 3007710611
- FEI Number
- 3007710611
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Am Hegelesberg 1
- City
- Kirchheim unter Teck Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K090160
Owner / Operator
- Firm Name
- Polymedics Innovations
- Operator Number
- 10029744
- Address
- Am Hegelesberg 1
- City
- Kirchheim unter Teck
- State
- Baden-Wurttemberg
- Postal Code
- 73230
- Country
- DE
- Correspondent
- Christian Planck
US Agent
- Business Name
- Quality Systems Resources (QSR)
- Contact Name
- Kenneth Kleinhenz
- Address
- 10807 Dakota Ranch Road
- City
- Santee
- State
- CA
- ZIP
- 92071
- Country
- US
- [email protected]
- Phone
- 619 2449573
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | Class U | Unknown | No | 2009-06-22 |
Proprietary Names
Suprathel Hand
Suprathel CW
Suprathel Wound and Burn Dressing
Establishment Types
Manufacture Medical Device