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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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bawmed rescue mask BAWMED UK k031431 07/13/2004
dover rob-nel catheter TYCO HEALTHCARE k040897 07/20/2004
microlife upper arm blood pressure monitor, model bp-3bto-ap MICROLIFE CORP. k041411 07/21/2004
hemosure one-step fecal occult blood test W.H.P.M., INC. k041202 08/12/2004
digital flexible thermometer, basic digital thermometer, ditital pacifier thermometer HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., k041694 09/13/2004
scb/valleylab force fx interface unit KARL STORZ ENDOSCOPY-AMERICA, INC. k041912 10/25/2004
quill synthetic absorbable barbed suture QUILL MEDICAL, INC. k042075 10/26/2004
vasc-alert VASC-ALERT, INC. k042566 11/08/2004
liquichek urine toxicology control, (levels s1s and s2s) BIO-RAD k042865 11/24/2004
vigilance ii continuous cardiac output/oximetry/volumetric monitor, model vig2 EDWARDS LIFESCIENCES, LLC. k043103 12/09/2004

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