FDA Registration
Active
🇺🇸 United States
INFRAVISION 48 FR. ESOPHAGEAL KIT
Reg #: 2936485
·
FEI: 2936485
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- STRYKER ENDOSCOPY
- Registration Number
- 2936485
- FEI Number
- 2936485
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5900 Optical Ct
- City
- SAN JOSE
- State
- CA
- ZIP
- 95138
- Country
- US
Regulatory Submissions
- 510(k) Number
- K983220
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | FAT | Class 2 | Gastroenterology, Urology | No | 2008-01-24 |
Proprietary Names
INFRAVISION 48 FR. ESOPHAGEAL KIT
INFRAVISION 50 FR. ESOPHAGEAL KIT
Infrvision Esophageal Kit
INFRAVISION 56 FR. ESOPHAGEAL KIT
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device