FDA Registration
Active
🇺🇸 United States
SURGICAL TECHNOLOGY LABORATORIES INC.
Reg #: 1825527
·
FEI: 1825527
·
Expires 2026
Products
7
Proprietary Names
13
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- SURGICAL TECHNOLOGY LABORATORIES INC.
- Registration Number
- 1825527
- FEI Number
- 1825527
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1566 Whiting Way
- City
- Lugoff
- State
- SC
- ZIP
- 29078
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091011
Owner / Operator
- Firm Name
- SURGICAL TECHNOLOGY LABORATORIES INC.
- Operator Number
- 1825527
- Address
- 1566 Whiting Way, --
- City
- Lugoff
- State
- SC
- Postal Code
- 29078
- Country
- US
- Correspondent
- MATHEW - FAIRFAX
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Nasal | EPP | Class 1 | Ear, Nose, Throat | No | 1979-05-22 |
| Prosthesis, Chin, Internal | FWP | Class 2 | General, Plastic Surgery | No | 2010-01-12 |
| Implant, Malar | LZK | Class 2 | General, Plastic Surgery | No | 2010-01-12 |
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | Class 2 | General, Plastic Surgery | No | 2007-12-11 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2007-12-11 |
| Silicone Hydrogel For Scar Management | PFP | Class 1 | General, Plastic Surgery | No | 2023-06-23 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-06-05 |
Proprietary Names
SurgiPlast
PureForm
SFAM
SFAM 3-D
Surgiform Augmentation Material
Straith Nasal Implant
Odifile Nasal Implant
Surgiform Nasal Implant
ScarX
Surgiform Chin Implant
Straight Chin
Surgiform Malar Implant
Saf-T-Vac Smoke and Fluid Evacuator
Establishment Types
Manufacture Medical Device