FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
K Number: K181787
·
Decision Apr 25, 2019
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
48
Applicant Total
3
Review Days
294
Basic Information
- Device Name
- Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
- K Number
- K181787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cedic S.r.l.
- Date Received
- July 5, 2018
- Decision Date
- April 25, 2019
- Product Code
- PIF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | FDA class 2 | Gastroenterology, Urology |
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