FDA Registration
Active
🇺🇸 United States
INSERT MOLDING SOLUTIONS, INC.
Reg #: 3009050824
·
FEI: 3009050824
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- INSERT MOLDING SOLUTIONS, INC.
- Registration Number
- 3009050824
- FEI Number
- 3009050824
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4325 Settingdown Cir Ste 103
- City
- Cumming
- State
- GA
- ZIP
- 30028
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162313
Owner / Operator
- Firm Name
- Insert Molding Solutions, Inc.
- Operator Number
- 10044415
- Address
- 4325 Settingdown Circle, Suite 103
- City
- Cumming
- State
- GA
- Postal Code
- 30028
- Country
- US
- Correspondent
- Paul H Hendrixson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-01-15 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-15 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2025-01-15 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-15 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-01-15 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-01-15 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)