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

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..

Clearance details

Applicant: Micro Specialties, Inc.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 1998-02-10
Decision date: 1998-05-01
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.