CLOSED WOUND DRAINAGE SYSTEMS— 510(k) K874645

Name: FDA 510(k) clearance K874645
Creator: U.S. Food and Drug Administration
Published: 1987-12-02

Substantially Equivalent

Hall Laboratories, Inc.

FDA 510(k) clearance K874645 for CLOSED WOUND DRAINAGE SYSTEMS, Substantially Equivalent on 1987-12-02. Applicant: Hall Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Hall Laboratories, Inc.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1987-11-13
Decision date: 1987-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Merriam, KS, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.