U&U Sterilization Pouch and Roll— 510(k) K143637

Substantially Equivalent

U&U Medical Technology Co, Ltd.

FDA 510(k) clearance K143637 for U&U Sterilization Pouch and Roll, Substantially Equivalent on 2015-09-09. Applicant: U&U Medical Technology Co, Ltd..

Clearance details

Applicant
U&U Medical Technology Co, Ltd.
Product code
Code FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Changzhou,Jiangshu, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code FRG

product code FRG
Other
3
Total
3

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.