PLANCON MIRCOLAMELLAR KERATOME— 510(k) K960395

Name: FDA 510(k) clearance K960395
Creator: U.S. Food and Drug Administration
Published: 1996-04-26

Substantially Equivalent

Plancon Instruments

FDA 510(k) clearance K960395 for PLANCON MIRCOLAMELLAR KERATOME, Substantially Equivalent on 1996-04-26. Applicant: Plancon Instruments. Device class: 1.

Clearance details

Applicant: Plancon Instruments
Product code: Code HNO
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 1996-01-29
Decision date: 1996-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antony, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

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.