SOFT LENS FOLDING BLOCK— 510(k) K891487

Substantially Equivalent

Western Medical Products, Inc.

FDA 510(k) clearance K891487 for SOFT LENS FOLDING BLOCK, Substantially Equivalent on 1989-08-15. Applicant: Western Medical Products, Inc..

Clearance details

Applicant: Western Medical Products, Inc.
Product code: Code HNR
Advisory panel: Ophthalmic
Date received: 1989-03-17
Decision date: 1989-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.