KRATZ NOVA-SERT— 510(k) K871440

Substantially Equivalent

CooperVision, Inc.

FDA 510(k) clearance K871440 for KRATZ NOVA-SERT, Substantially Equivalent on 1987-05-07. Applicant: CooperVision, Inc..

Clearance details

Applicant: CooperVision, Inc.
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 1987-04-13
Decision date: 1987-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

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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.