LAKE OSTOMY CARE SET— 510(k) K922730

Name: FDA 510(k) clearance K922730
Creator: U.S. Food and Drug Administration
Published: 1993-12-30

Unknown

Lake Medical Products, Inc.

FDA 510(k) clearance K922730 for LAKE OSTOMY CARE SET, Unknown on 1993-12-30. Applicant: Lake Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Lake Medical Products, Inc.
Product code: Code EXB
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 1992-06-05
Decision date: 1993-12-30
Decision: Unknown
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EXB

product code EXB

Injury: 145
Total: 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.