SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M— 510(k) K910783

Name: FDA 510(k) clearance K910783
Creator: U.S. Food and Drug Administration
Published: 1991-04-02

Substantially Equivalent

Smith & Nephew Equipment Group

FDA 510(k) clearance K910783 for SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M, Substantially Equivalent on 1991-04-02. Applicant: Smith & Nephew Equipment Group. Device class: 1.

Clearance details

Applicant: Smith & Nephew Equipment Group
Product code: Code BWN
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1991-02-25
Decision date: 1991-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BWN

product code BWN

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.