KERATOME— 510(k) K903912

Substantially Equivalent

Micro Precision Instrument Co.

FDA 510(k) clearance K903912 for KERATOME, Substantially Equivalent on 1990-10-17. Applicant: Micro Precision Instrument Co..

Clearance details

Applicant: Micro Precision Instrument Co.
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 1990-08-24
Decision date: 1990-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AR, US

Download summary PDF View on FDA.gov ↗

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.