Sterile Hypodermic Safety Syringes for Single Use— 510(k) K163162

Substantially Equivalent

Jiangxi Hongda Medical Equipment Group , Ltd.

FDA 510(k) clearance K163162 for Sterile Hypodermic Safety Syringes for Single Use, Substantially Equivalent on 2017-03-20. Applicant: Jiangxi Hongda Medical Equipment Group , Ltd..

Clearance details

Applicant
Jiangxi Hongda Medical Equipment Group , Ltd.
Product code
Code MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Nanchang, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code MEG

product code MEG
Malfunction
1,373
Other
1
Total
1,374

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.