RETRACTIVE INCISION MICROMETER (RIM) GUAGE— 510(k) K882402

Substantially Equivalent

Optical Center

FDA 510(k) clearance K882402 for RETRACTIVE INCISION MICROMETER (RIM) GUAGE, Substantially Equivalent on 1988-08-22. Applicant: Optical Center.

Clearance details

Applicant: Optical Center
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1988-06-10
Decision date: 1988-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxnard, CA, US

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Adverse events under product code HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

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.