NLD IMPLANT SET— 510(k) K813314

Name: FDA 510(k) clearance K813314
Creator: U.S. Food and Drug Administration
Published: 1982-02-24

Substantially Equivalent

Design Research Assoc., Inc.

FDA 510(k) clearance K813314 for NLD IMPLANT SET, Substantially Equivalent on 1982-02-24. Applicant: Design Research Assoc., Inc.. Device class: 1.

Clearance details

Applicant: Design Research Assoc., Inc.
Product code: Code HMX
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1981-11-24
Decision date: 1982-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K813313 — BIOMICROSCOPY CONTACT LENS1982-03-01
K813315 — CALIPER-OPTHALMIC1982-03-01

Adverse events under product code HMX

product code HMX

Other: 1
Total: 1

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.