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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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acuglide brand acupuncture needles HELIO MEDICAL SUPPLIES, INC. k012583 12/11/2001
modification to: ultralon (r) powder free latex surgical gloves ANSELL HEALTHCARE PRODUCTS, INC. k013604 11/13/2001
electro neuromuscular stimulator, model nms-digital BIOMEDICAL LIFE SYSTEMS, INC. k010749 09/28/2001
mx8000 idt ct system MARCONI MEDICAL SYSTEMS, INC. k012009 09/13/2001
es-2000 shape select electrosurgical scalpel SENORX, INC. k012799 09/04/2001
human igg subclass liquid reagent kits, product code lk001.t THE BINDING SITE, LTD. k012296 08/31/2001
esteem sterile polyisoprene surgical gloves ALLEGIANCE HEALTHCARE CORP. k011721 08/14/2001
splittable sheath introducer kit THOMAS MEDICAL PRODUCTS, INC. k004025 07/19/2001
cyclosporine calibrator DADE BEHRING, INC. k011112 07/17/2001
spacelabs medical anesthesia delivery system (ads) with pressure control mode SPACELABS MEDICAL, INC. k003663 06/28/2001

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