BUONAFEDE PNEUMATIC SLEEVE— 510(k) K954201

Name: FDA 510(k) clearance K954201
Creator: U.S. Food and Drug Administration
Published: 1995-11-09

Substantially Equivalent

Promedic, Inc.

FDA 510(k) clearance K954201 for BUONAFEDE PNEUMATIC SLEEVE, Substantially Equivalent on 1995-11-09. Applicant: Promedic, Inc.. Device class: 1.

Clearance details

Applicant: Promedic, Inc.
Product code: Code KCY
Device class: Class 1
Regulation: 21 CFR 878.5910
Advisory panel: General, Plastic Surgery
Date received: 1995-09-06
Decision date: 1995-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturgis, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.