MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700— 510(k) K880337

Name: FDA 510(k) clearance K880337
Creator: U.S. Food and Drug Administration
Published: 1988-04-14

Substantially Equivalent

Plasco, Inc.

FDA 510(k) clearance K880337 for MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700, Substantially Equivalent on 1988-04-14. Applicant: Plasco, Inc.. Device class: 1.

Clearance details

Applicant: Plasco, Inc.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1988-01-26
Decision date: 1988-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gurnee, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FCE

product code FCE

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.