KERATOME BLADE 200200 & 600600— 510(k) K020482

Substantially Equivalent

Micro Specialties, Inc.

FDA 510(k) clearance K020482 for KERATOME BLADE 200200 & 600600, Substantially Equivalent on 2002-12-16. Applicant: Micro Specialties, Inc..

Clearance details

Applicant: Micro Specialties, Inc.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2002-02-13
Decision date: 2002-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, CT, US

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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.