DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS— 510(k) K863040

Substantially Equivalent

Cher Mel Corp.

FDA 510(k) clearance K863040 for DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS, Substantially Equivalent on 1986-10-31. Applicant: Cher Mel Corp..

Clearance details

Applicant: Cher Mel Corp.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1986-08-12
Decision date: 1986-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.