FDA Registration
Active
🇺🇸 United States
EarPopper
Reg #: 3008719017
·
FEI: 3008719017
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SUMMIT MEDICAL LLC
- Registration Number
- 3008719017
- FEI Number
- 3008719017
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 815 Vikings Pkwy Ste 100
- City
- Saint Paul
- State
- MN
- ZIP
- 55121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K073401
Owner / Operator
- Firm Name
- Summit Medical, LLC
- Operator Number
- 10033920
- Address
- 815 Vikings Parkway, Suite 100
- City
- Saint Paul
- State
- MN
- Postal Code
- 55121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Inflation, Middle Ear | MJV | Class U | Unknown | No | 2010-10-19 |
Proprietary Names
EarPopper
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device