FDA Registration
Active
🇺🇸 United States
VacSure EZ CARE Pressure Activate Safety Lancet
Reg #: 3010194621
·
FEI: 3010194621
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LABOTEK GROUP CORP
- Registration Number
- 3010194621
- FEI Number
- 3010194621
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- CARR 174 KM 4.5 BO JUAN SANCHEZ
- City
- Bayamon
- State
- PR
- ZIP
- 00956
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222376
Owner / Operator
- Firm Name
- LABOTEK GROUP CORP.
- Operator Number
- 10044096
- Address
- CARR 174 KM 4.5 BO JUAN SANCHEZ
- City
- Bayamon
- State
- PR
- Postal Code
- 00956
- Country
- US
- Correspondent
- MARISOL AROCHO
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2024-04-30 |
Proprietary Names
VacSure EZ CARE Pressure Activate Safety Lancet
Establishment Types
Repack or Relabel Medical Device