EMPTY SOLUTION TRANSFER CONTAINER 1000— 510(k) K843523

Substantially Equivalent

Polymer Technology Corp.

FDA 510(k) clearance K843523 for EMPTY SOLUTION TRANSFER CONTAINER 1000, Substantially Equivalent on 1984-10-16. Applicant: Polymer Technology Corp..

Clearance details

Applicant: Polymer Technology Corp.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1984-09-07
Decision date: 1984-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whitwater, WI, 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.