Cleared Traditional

ALPHAMED SURGICAL SPEAR, MODEL 70-5000

K091240 · Alphamed, Inc. · Ophthalmic
Oct 2009
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K091240 is an FDA 510(k) clearance for the ALPHAMED SURGICAL SPEAR, MODEL 70-5000, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Alphamed, Inc. (El Paso, US). The FDA issued a Cleared decision on October 23, 2009, 179 days after receiving the submission on April 27, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K091240 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2009
Decision Date October 23, 2009
Days to Decision 179 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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