STERILIZATION TRAY LINER— 510(k) K893764

Name: FDA 510(k) clearance K893764
Creator: U.S. Food and Drug Administration
Published: 1989-08-15

Substantially Equivalent

Ahlstrom Dexter

FDA 510(k) clearance K893764 for STERILIZATION TRAY LINER, Substantially Equivalent on 1989-08-15. Applicant: Ahlstrom Dexter. Device class: 2.

Clearance details

Applicant: Ahlstrom Dexter
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1989-05-19
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windsor Locks, CT, US

Download summary PDF View on FDA.gov ↗

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K933550 — HYDRASPUN M STERILIZATION WRAP1994-03-29
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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.