MASH DERMATOME— 510(k) K861138

Name: FDA 510(k) clearance K861138
Creator: U.S. Food and Drug Administration
Published: 1986-04-14

Substantially Equivalent

Mecron Medical Products, Inc.

FDA 510(k) clearance K861138 for MASH DERMATOME, Substantially Equivalent on 1986-04-14. Applicant: Mecron Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Mecron Medical Products, Inc.
Product code: Code GFD
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1986-03-26
Decision date: 1986-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Washington, NY, US

Download summary PDF View on FDA.gov ↗

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K844488 — MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS1985-03-12
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Adverse events under product code GFD

product code GFD

Injury: 544
Malfunction: 3,575
Other: 1
Total: 4,120

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.