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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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umeco optima multiline laser system MEDICAL LASER SOLUTIONS LLC. k000693 05/16/2000
pbn hystero-salpingography catheter set MEDICAL DEVICE TECHNOLOGIES, INC. k000433 06/16/2000
escort ii+ 400 series (escort prism), model 20400, 20401, 20403, monitor, models 20411, 20412, 20413 MEDICAL DATA ELECTRONICS k000660 03/28/2000
acti-gard antimicrobial film, models d6635, d6640, d6648, d6650,d6651, d66xx MEDICAL CONCEPTS DEVELOPMENT, INC. k000442 04/24/2001
prolite vl pulsed light system MEDICAL BIO CARE SWEDEN AB k002072 09/11/2000
theratron 780c/1000 with computerized console upgrade MDS NORDION k001006 04/27/2000
introducer with distal radiopaque marker band, model or-4926xx MAXXIM MEDICAL k002847 05/31/2001
matang powdered latex patient examination glove with protein labeling claim (50 microgram or less MATANG MFG. SDN. BHD. k000985 04/24/2000
masimo set radical pulse oximeter with satshare and lnop series of sensors and cables MASIMO CORP. k002477 09/08/2000
modification to masimo set radical pulse oximeter with satshare and lnop series of sensors and cables MASIMO CORP. k003244 11/08/2000

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