FDA Registration
Active
🇺🇸 United States
Multiple
Reg #: 1222301
·
FEI: 1000121071
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ACME-MONACO CORP.
- Registration Number
- 1222301
- FEI Number
- 1000121071
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1450 Central Drive
- City
- PRESQUE ISLE
- State
- ME
- ZIP
- 04769
- Country
- US
Regulatory Submissions
- 510(k) Number
- K920884
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 |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-11-27 |
Proprietary Names
Multiple
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device