OPHTHALMIC SPONGES— 510(k) K920354

Name: FDA 510(k) clearance K920354
Creator: U.S. Food and Drug Administration
Published: 1992-08-05

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K920354 for OPHTHALMIC SPONGES, Substantially Equivalent on 1992-08-05. Applicant: Ultracell Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ultracell Medical Technologies, Inc.
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 1992-01-27
Decision date: 1992-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Stonington, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ultracell Medical Technologies, Inc.

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Recalls naming K920354

K-number listed on FDA's recall record

Z-1199-2023 — Ultracell Wick with 80cc Collection Bag, 20/boxClass II·Ongoing·Beaver Visitec International, Inc.·20221220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K920354.

Data sourced from openFDA. This site is unofficial and independent of the FDA.