FDA Registration
Active
🇺🇸 United States
Puregraft 850
Reg #: 3022978896
·
FEI: 3022978896
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Bimini Health Tech
- Registration Number
- 3022978896
- FEI Number
- 3022978896
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8400 Belleview Drive, Ste. 125
- City
- Plano
- State
- TX
- ZIP
- 75024
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK220693
Owner / Operator
- Firm Name
- Bimini Health Tech
- Operator Number
- 10048045
- Address
- 8400 Belleview Drive, Suite 125
- City
- Plano
- State
- TX
- Postal Code
- 75024
- Country
- US
- Correspondent
- Frankie Ng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | Class 2 | General, Plastic Surgery | No | 2023-07-14 |
Proprietary Names
Puregraft 850
Puregraft 850 Twin Pack
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198