ENEMA KIT— 510(k) K761167

Substantially Equivalent

American Hospital Supply Corp.

FDA 510(k) clearance K761167 for ENEMA KIT, Substantially Equivalent on 1976-12-09. Applicant: American Hospital Supply Corp..

Clearance details

Applicant: American Hospital Supply Corp.
Product code: Code FCE
Advisory panel: Gastroenterology, Urology
Date received: 1976-12-01
Decision date: 1976-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.