KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600— 510(k) K082554

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K082554 for KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600, Substantially Equivalent on 2009-05-01. Applicant: Kimberly-Clark Corp..

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code FRG
Advisory panel: General Hospital
Date received: 2008-09-03
Decision date: 2009-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dawsonville, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

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.