Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)— 510(k) K200557
Substantially EquivalentJiangsu Shenli Medical Production Co., Ltd.
FDA 510(k) clearance K200557 for Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring), Substantially Equivalent on 2020-09-28. Applicant: Jiangsu Shenli Medical Production Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jiangsu Shenli Medical Production Co., Ltd.
- Product code
- Code PNR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou City, CN
Recent devices under product code PNR
view allMore clearances from Jiangsu Shenli Medical Production Co., Ltd.
view allAdverse events under product code PNR
product code PNR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.