OCULAR INFUSION CANNULA SYSTEM— 510(k) K901618

Name: FDA 510(k) clearance K901618
Creator: U.S. Food and Drug Administration
Published: 1990-05-31

Substantially Equivalent

Tamcenan Corp.

FDA 510(k) clearance K901618 for OCULAR INFUSION CANNULA SYSTEM, Substantially Equivalent on 1990-05-31. Applicant: Tamcenan Corp.. Device class: 1.

Clearance details

Applicant: Tamcenan Corp.
Product code: Code HMX
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1990-04-06
Decision date: 1990-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sioux Falls, SD, US

Download summary PDF View on FDA.gov ↗

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K905750 — LACRIMAL PLUG1991-03-14
K902308 — TAMCENAN OCULAR EXPLANTS AND BANDS1990-06-19

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.