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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
Date
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reprocessed external fixation device STERILMED, INC. k083636 03/02/2009
sonotip ii 25-gauge ultrasound needle system, models gus-01-18-025 and gus-01-27-025 MEDI-GLOBE CORPORATION k083802 03/20/2009
apk spo2 pulse oximeter sensor APK TECHNOLOGY CO., LTD k082846 04/03/2009
ya horng digital upper arm blood pressure monitor, bp-700, bp-700t, bp700u, bp-700b, bp-700tb, bp-700ub, bp-700tub YA HORNG ELECTRONIC CO., LTD. k090058 04/22/2009
portex tuohy epidural needle 17g, portex tuohy epidural needle 18g SMITHS MEDICAL ASD, INC. k090261 05/01/2009
easy on-pc spirometer NDD MEDIZITECHNIK AG k090034 06/02/2009
synthes oracle plate SYNTHES SPINE k091159 07/10/2009
vinyl powdered examination glove SHUN TONG CO., LTD k091384 07/20/2009
vascu-picc and midline catheters, single, double and triple lumen MEDCOMP k091586 07/23/2009
gsp instrument and gsp neonatal htsh kit PERKINELMER, INC. k090846 09/03/2009

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