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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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510(K)
Number
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Decision
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renew ls-1 Bisco, Inc. k003317 11/21/2000
microlife digital infrared ear thermometer, ir1dai, ir1db1, ir1dd1 Microlife Corp. k003308 11/14/2000
replace tps coated implants Nobel Biocare Uas, Inc. k002475 11/09/2000
lumboperitoneal shunt system Phoenix Biomedical Corp. k002476 11/09/2000
precimed trauma system Patrick Berdoz k002486 11/09/2000
fetalgard lite Analogic Corp. k002503 11/09/2000
pagewriter 10/10i, model m2662a handheld electrocardiograph Agilent Technologies, Inc. k002459 11/08/2000
stellar Skytron, Div. the Kmw Group, Inc. k002463 11/08/2000
wec-7101a pocket size ecg monitor and accessories Nihon Kohden America, Inc. k002473 11/08/2000
brentwood iqmark digital spirometer (includes disposable pneumotach mouthpieces and 3-liter calibration syringe Brentwood Medical Technology Corp. k002499 11/08/2000

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