KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)— 510(k) K980510

Name: FDA 510(k) clearance K980510
Creator: U.S. Food and Drug Administration
Published: 1998-05-01

Substantially Equivalent

Micro Specialties, Inc.

FDA 510(k) clearance K980510 for KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020), Substantially Equivalent on 1998-05-01. Applicant: Micro Specialties, Inc.. Device class: 1.

Clearance details

Applicant: Micro Specialties, Inc.
Product code: Code HNO
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 1998-02-10
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, US

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.