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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
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optimesh SPINEOLOGY, INC. k014200 11/26/2003
glucoleader value HMD BIOMEDICAL, INC. k023279 08/04/2003
suile wound dressing HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. k022967 07/08/2003
fisher & paykel healthecare oracle oral mask FISHER & PAYKEL HEALTHCARE, LTD. k023559 06/12/2003
cook vascular serpenta coronary sinus introducer system COOK VASCULAR, INC. k023937 05/27/2003
codman isocool bipolar forceps Codman & Shurtleff, Inc. k023566 05/22/2003
steritite container with flashtite valve plate(s) & meditray products CASE MEDICAL, INC. k022978 05/09/2003
surgical simplex p with tobramycin HOWMEDICA OSTEONICS CORP. k014199 05/06/2003
carecompanion patient station/carecompanion patient station NEPTEC DESIGN GROUP, LTD. k023286 05/02/2003
sterrad 50 & sterrad 100s sterilizers ADVANCED STERILIZATION PRODUCTS k023290 04/03/2003

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