Cleared Traditional

OPHTHALMIC SPONGES

K950241 · Oasis Medical, Inc. · Ophthalmic
Feb 1995
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K950241 is an FDA 510(k) clearance for the OPHTHALMIC SPONGES, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on February 27, 1995, 38 days after receiving the submission on January 20, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K950241 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 1995
Decision Date February 27, 1995
Days to Decision 38 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HOZ — Sponge, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4790

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