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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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surx radiofrequency electrosurgical generator system and accessories (surx lp system) SURX, INC. k011190 01/08/2002
duraprene sterile synthetic powder-free surgical gloves with tested for use with chemotherapy drugs labeling claim ALLEGIANCE HEALTHCARE CORP. k013302 12/17/2001
stent support guide catheter MEDTRONIC VASCULAR k010579 11/21/2001
diamedix is-anti-gliadin iga test system DIAMEDIX CORP. k012797 09/28/2001
fadasis medical fm-1 no blender FADASIS MEDICAL, INC. k011874 07/20/2001
safe at home tsh (thyroid stimulating hormone blood collection and transport system) BIOSAFE LABORATORIES, INC. k011525 07/16/2001
easy control micro inserter, model on385 OPHTEC USA, INC. k011498 07/09/2001
laparoscopic hand port APPLIED MEDICAL RESOURCES CORP. k003871 05/31/2001
premier ultrasonic scaler and inserts PREMIER DENTAL PRODUCTS CO. k010195 04/17/2001
the liberator wheelchair LIBERATOR WHEELCHAIRS, INC. k010859 04/05/2001

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