CENEFOM PVA SURGICAL SPEAR— 510(k) K082460

Name: FDA 510(k) clearance K082460
Creator: U.S. Food and Drug Administration
Published: 2008-12-15

Substantially Equivalent

Longtek Scientific Co., Ltd.

FDA 510(k) clearance K082460 for CENEFOM PVA SURGICAL SPEAR, Substantially Equivalent on 2008-12-15. Applicant: Longtek Scientific Co., Ltd.. Device class: 2.

Clearance details

Applicant: Longtek Scientific Co., Ltd.
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 2008-08-26
Decision date: 2008-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HOZ

view all

K132796 — SUNTOUCH EYE SPEAR2013-10-30
K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS2013-10-29
K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-50002009-10-23
K012196 — ULTRACELL ABSORBENT STICK2001-08-24
K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES2001-06-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.