SCMD KERATOME— 510(k) K935342

Name: FDA 510(k) clearance K935342
Creator: U.S. Food and Drug Administration
Published: 1994-04-01

Substantially Equivalent

S.C.M.D. Keratomes of Arizona

FDA 510(k) clearance K935342 for SCMD KERATOME, Substantially Equivalent on 1994-04-01. Applicant: S.C.M.D. Keratomes of Arizona. Device class: 1.

Clearance details

Applicant: S.C.M.D. Keratomes of Arizona
Product code: Code HNO
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 1993-11-05
Decision date: 1994-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ftn. Hills, AZ, 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.