Cleared Traditional

CENEFOM PVA SURGICAL SPEAR

K082460 · Longtek Scientific Co., Ltd. · Ophthalmic
Dec 2008
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K082460 is an FDA 510(k) clearance for the CENEFOM PVA SURGICAL SPEAR, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Longtek Scientific Co., Ltd. (Houston, US). The FDA issued a Cleared decision on December 15, 2008, 111 days after receiving the submission on August 26, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K082460 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2008
Decision Date December 15, 2008
Days to Decision 111 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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