510(k) K062932— AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER

Substantially Equivalent

Ahlstrom Mount Holly Springs, LLC

Clearance details

Applicant: Ahlstrom Mount Holly Springs, LLC
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2006-09-28
Decision date: 2007-10-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mount Holly Springs, PA, US

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.