SOFT SOCK— 510(k) K944240

Name: FDA 510(k) clearance K944240
Creator: U.S. Food and Drug Administration
Published: 1994-12-27

Substantially Equivalent

Silipos, Inc.

FDA 510(k) clearance K944240 for SOFT SOCK, Substantially Equivalent on 1994-12-27. Applicant: Silipos, Inc.. Device class: 1.

Clearance details

Applicant: Silipos, Inc.
Product code: Code FQL
Device class: Class 1
Regulation: 21 CFR 880.5780
Advisory panel: General Hospital
Date received: 1994-09-01
Decision date: 1994-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niagra Falls, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQL

product code FQL

Other: 1
Total: 1

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.