FDA Registration
Active
🇺🇸 United States
HCS
Reg #: 3007407626
·
FEI: 3007407626
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Mazza Healthcare LLC
- Registration Number
- 3007407626
- FEI Number
- 3007407626
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2101 Waukegan Rd - Suite 208
- City
- Bannockburn
- State
- IL
- ZIP
- 60015
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223375
Owner / Operator
- Firm Name
- Mazza Healthcare, LLC
- Operator Number
- 10028309
- Address
- 2101 Waukegan Road, Suite 208
- City
- Bannockburn
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Michael A Mazza
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-11-27 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-11-27 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-11-27 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-11-27 |
Proprietary Names
HCS
Establishment Types
Complaint File Establishment per 21 CFR 820.198