FDA Registration
Active
🇺🇸 United States
Guidewire
Reg #: 1293141
·
FEI: 1293141
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ACME-MONACO CORP.
- Registration Number
- 1293141
- FEI Number
- 1293141
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 75 Winchell Rd
- City
- NEW BRITAIN
- State
- CT
- ZIP
- 06052
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101199
Owner / Operator
- Firm Name
- ACME-MONACO CORP.
- Operator Number
- 1293141
- Address
- 75 WINCHELL DR., --
- City
- New Britain
- State
- CT
- Postal Code
- 06052
- Country
- US
- Correspondent
- REBECCA - KARABIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2013-06-06 |
Proprietary Names
Guidewire
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)