DUOPRO SAFETY SYRINGE (DUOPROSS)— 510(k) K020623

Substantially Equivalent

M.K. Meditech Co. , Ltd.

FDA 510(k) clearance K020623 for DUOPRO SAFETY SYRINGE (DUOPROSS), Substantially Equivalent on 2002-05-02. Applicant: M.K. Meditech Co. , Ltd..

Clearance details

Applicant
M.K. Meditech Co. , Ltd.
Product code
Code MEG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Attleboro, MA, US
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.