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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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zoe medical nightingale monitoring system Zoe Medical, Inc. k001775 01/12/2001
z2 balloon guided pacing & pressure monitoring catheter, model z2-7-02-1-10-0 Zcv ,Inc. k003118 12/20/2000
young-health super ear thermometer Young Health Ind. Co., Ltd. k002727 06/13/2001
bufflight clt surgical laser system Y-Beam Technologies, Inc. k000727 09/19/2000
electrosurgical probes and devices-geltx Ximed/Prosure/Injectx k002269 01/04/2001
coaxial dilator set Xentek Medical, Inc. k000737 08/01/2000
dermagrip powder free blue polymer coated latex examination glove, non-sterile contains 50 microgram or less of total wa Wrp Specialty Products Sdn. Bhd. k003132 11/17/2000
laryngo-tracheal mucosal atomization device (madgic) Wolfe Tory Medical, Inc. k002255 09/18/2000
neocare 20 micron blood filter Whatman, Inc. k000719 05/30/2000
acticoat foam dressing Westaim Biomedical, Inc. k000051 04/05/2000

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