FDA Registration
Active
🇺🇸 United States
Laparoscope, Gynecologic(and accessories)
Reg #: 1720747
·
FEI: 1720747
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SONTEC INSTRUMENTS, INC.
- Registration Number
- 1720747
- FEI Number
- 1720747
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7248 SOUTH TUCSON WAY
- City
- CENTENNIAL
- State
- CO
- ZIP
- 80112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002877
Owner / Operator
- Firm Name
- SONTEC INSTRUMENTS, INC.
- Operator Number
- 1720747
- Address
- 7248 SOUTH TUCSON WAY, --
- City
- Centennial
- State
- CO
- Postal Code
- 80112
- Country
- US
- Correspondent
- Jill - Thacker
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2010-06-02 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2010-06-02 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2010-06-02 |
Proprietary Names
Laparoscope, Gynecologic(and accessories)
Electrosurgical, cutting & coagulation & accessories
Laparoscope, general & plastic surgery
Establishment Types
Repack or Relabel Medical Device