FDA Registration
Active
🇺🇸 United States
Tumark Professional Q
Reg #: 1222780
·
FEI: 1000120743
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HOLOGIC, INC.
- Registration Number
- 1222780
- FEI Number
- 1000120743
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 250 Campus Dr
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
Regulatory Submissions
- 510(k) Number
- K073095
Owner / Operator
- Firm Name
- HOLOGIC, INC.
- Operator Number
- 9007676
- Address
- 250 Campus Drive, --
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2017-03-24 |
Proprietary Names
Tumark Professional Q
Establishment Types
Complaint File Establishment per 21 CFR 820.198