FDA Registration
Active
🇺🇸 United States
THERMOFLATOR, Model 26 4320 20
Reg #: 1221826
·
FEI: 1221826
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KARL STORZ ENDOVISION, INC.
- Registration Number
- 1221826
- FEI Number
- 1221826
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 91 Carpenter Hill Rd
- City
- CHARLTON
- State
- MA
- ZIP
- 01507
- Country
- US
Regulatory Submissions
- 510(k) Number
- K955073
Owner / Operator
- Firm Name
- KARL STORZ SE & CO KG
- Operator Number
- 8010119
- Address
- Dr.-Karl-Storz-Strasse 34,
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2007-11-20 |
Proprietary Names
THERMOFLATOR, Model 26 4320 20
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)