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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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vapr 2.3mm wedge electrode for use with vapr system MITEK PRODUCTS k000936 04/19/2000
opi band ORTHOMERICA PRODUCTS, INC. k001167 07/07/2000
disposable pvc synthetic exam gloves, powder free SHANGHAI PM PLASTICS ENT. CO., LTD. k001432 07/05/2000
tpn nutrition bag (eva), emptying tube, bag syringe fill set BIOMETRIX LTD. k001461 09/11/2000
medis 2mp2 dual-head medical diagnostic display system BARCO NV DISPLAY SYSTEMS k001747 07/13/2000
tri-lock hip stem DEPUY ORTHOPAEDICS, INC. k001982 07/26/2000
colleague cx volumetric infusion pump 2m8161 and volumeteric infusion pump 2m8151 BAXTER HEALTHCARE CORP. k002211 07/28/2000
equipment drapes ALLEGIANCE HEALTHCARE CORP. k002508 09/01/2000
sphygmocor mx model scor-mx PWV MEDICAL PTY, LT. k002742 05/01/2001
merogel control gel ent surgical dressing MEDTRONIC XOMED k002972 12/15/2000

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