FDA Registration
Active
🇺🇸 United States
StaySafe Clip; StaySafe Handi-Tool; StaySafe Organizer; StaySafe Organizer Holder
Reg #: 3003865400
·
FEI: 3003865400
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Maruho Plastic Solutions
- Registration Number
- 3003865400
- FEI Number
- 3003865400
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 425 BONNELL AVE.
- City
- ERIE
- State
- CO
- ZIP
- 80516
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173718
Owner / Operator
- Firm Name
- Maruho Plastic Solutions
- Operator Number
- 9045656
- Address
- 425 BONNELL AVE., --
- City
- Erie
- State
- CO
- Postal Code
- 80516
- Country
- US
- Correspondent
- Kelsey - Fox
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2019-06-06 |
Proprietary Names
StaySafe Clip; StaySafe Handi-Tool; StaySafe Organizer; StaySafe Organizer Holder
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)