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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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ids5 image display system Sectra AB k001140 05/03/2000
modification to steathstation treatment guidance platform Medtronic Surgical Navigation k001153 05/03/2000
shuttle stop Isotis NV k000587 05/04/2000
yoshida wave pict cam intraoral camera, sigma biomedics sigmacam intraoral camera The Yoshida Dental Mfg. Co., Ltd. k000577 05/05/2000
serim leukocyte esterase test strips Serim Research Corp. k000578 05/05/2000
ultraedge keratome blade, model 374803 - acs Lasersight Technologies, Inc. k001144 05/05/2000
powder free sterile latex examination gloves Allegiance Healthcare Corp. k001141 05/09/2000
preface guiding sheath, models 2-603m, 2-703m, 2-803m, 2-903m, 2-1003m, 2-1103m Biosense Webster, Inc. k001139 05/10/2000
sysmex automated coagulation analyzer, model ca-6000 Dade Behring, Inc. k001145 05/11/2000
modification to envoy patient monitor Mennen Medical , Ltd. k000563 05/17/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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