PETRUS IOL GUIDE— 510(k) K840104

Substantially Equivalent

Precision-Cosmet Co., Inc.

FDA 510(k) clearance K840104 for PETRUS IOL GUIDE, Substantially Equivalent on 1984-04-24. Applicant: Precision-Cosmet Co., Inc..

Clearance details

Applicant: Precision-Cosmet Co., Inc.
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 1984-01-10
Decision date: 1984-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

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.