BIOPSY TRAY I & II— 510(k) K854095

Name: FDA 510(k) clearance K854095
Creator: U.S. Food and Drug Administration
Published: 1985-11-25

Unknown

North Coast Medi-Tek

FDA 510(k) clearance K854095 for BIOPSY TRAY I & II, Unknown on 1985-11-25. Applicant: North Coast Medi-Tek. Device class: 2.

Clearance details

Applicant: North Coast Medi-Tek
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1985-10-07
Decision date: 1985-11-25
Decision: Unknown
Clearance type: Traditional
Location: Eastlake, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.