Cleared Traditional

STERISEAL OPHTHALMIC CANNULA

K943932 · Pharma-Plast, Ltd. · Ophthalmic
Jan 1995
Decision
159d
Days
Class 1
Risk

About This 510(k) Submission

K943932 is an FDA 510(k) clearance for the STERISEAL OPHTHALMIC CANNULA, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Pharma-Plast, Ltd. (Redditch, Worcestershire, GB). The FDA issued a Cleared decision on January 18, 1995, 159 days after receiving the submission on August 12, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K943932 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1994
Decision Date January 18, 1995
Days to Decision 159 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HMX — Cannula, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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