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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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knee module for the stealthstation system MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES k012937 01/25/2002
cardioblate surgical ablation pen, model 60811c; cardioblate surgical ablation generator, model 60880 MEDTRONIC VASCULAR k013392 01/25/2002
weinmann somnomask GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS k013738 01/22/2002
powder-free latex examination gloves with aloe and protein claim, tested for use with chemotherapy drugs SHEN WEI (USA), INC. k013794 01/22/2002
powder-free latex examination gloves with aloe and protein claim, tested for use with chemotherapy drugs, green color SHEN WEI (USA), INC. k013795 01/22/2002
powder-free latex exam gloves with protein labeling (<50ug/g) SUPERGRADE HEALTHCARE PRODUCTS SDN. BHD. k014134 01/22/2002
stimulus - dissection instruments MEDTRONIC XOMED, INC. k014165 01/22/2002
advia 1650 cholinesterase assay BAYER DIAGNOSTICS CORP. k013750 01/18/2002
phillips m1175a/76a/77a component monitoring system; phillips v24/v26 patient monitor PHILIPS MEDICAL SYSTEMS, INC. k014159 01/18/2002
modification to dynalink .035 biliary self-expanding stent system GUIDANT CORP. k014184 01/18/2002

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