DeviceClearance

K880337

Substantially Equivalent

MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700

Applicant
Plasco, Inc.
Product code
FCE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gurnee, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FCE

product code FCE
Other
2
Total
2

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.