MAC LAVE STEAM STERILIZER— 510(k) K895275

Name: FDA 510(k) clearance K895275
Creator: U.S. Food and Drug Administration
Published: 1990-11-23

Substantially Equivalent

Merchants Export Development Corp.

FDA 510(k) clearance K895275 for MAC LAVE STEAM STERILIZER, Substantially Equivalent on 1990-11-23. Applicant: Merchants Export Development Corp.. Device class: 2.

Clearance details

Applicant: Merchants Export Development Corp.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 1989-08-23
Decision date: 1990-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K250164 — Cassette Autoclave (ACA5)2025-08-14

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.