DEXTEX II STERILIZATION WRAP— 510(k) K800123

Substantially Equivalent

Ahlstrom Dexter

FDA 510(k) clearance K800123 for DEXTEX II STERILIZATION WRAP, Substantially Equivalent on 1980-02-13. Applicant: Ahlstrom Dexter.

Clearance details

Applicant: Ahlstrom Dexter
Product code: Code FRG
Advisory panel: General Hospital
Date received: 1980-01-18
Decision date: 1980-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.