Cleared Traditional

ULTRACELL SUCTION SPONGE

K972633 · Ultracell Medical Technologies, Inc. · Ophthalmic
Dec 1997
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K972633 is an FDA 510(k) clearance for the ULTRACELL SUCTION SPONGE, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on December 17, 1997, 156 days after receiving the submission on July 14, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K972633 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1997
Decision Date December 17, 1997
Days to Decision 156 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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