ophthalmology products PVA Sponge with CE FDA:Material:PVA:Sterilization Method:Radiation:Shelf Life:5 years:Indications:1.Suitable use in ophthamic surgery 2.Have good performance in preoperative,intraoperative and post-operative actions 3.Frequent use in various specialist fields to absorb blood and secretion intraoperatively:Benefit
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PVA Sponge Spear (OPHTHALMIC SPONGE) Properties-These are high soaking capacity cellulose sponges that are mounted on plastic handles. The micropoint absorbent used is of superior quality & deliver optimum performance with our tear or shred.
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The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health Service Food and Drug Administration Longtek Scientific Co., Ltd. 9200 Corporate Boulevard c/o Joseph J. Chang, PhD, PE Rockville MD 20850 Innomedtech, LLC 7128 Staffordshire Street DEC 1 5 2008 Houston, TX 77030 Re:K082460 Trade/Device Name:Longtek Cenefom PVA Surgical Spear
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