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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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zynergy balloonpace balloon guided pacing and monitoring catheter ZCV ,INC. k002603 01/08/2001
laryngo-tracheal mucosal atomization device (madgic) WOLFE TORY MEDICAL, INC. k002255 09/18/2000
white knight masks (21 models, various colors with and without face shields) WHITE KNIGHT HEALTHCARE, INC. k001892 04/03/2001
white knight masks, blue, pink, yellow, white masks (13 models) WHITE KNIGHT HEALTHCARE, INC. k001893 04/02/2001
acticoat foam dressing WESTAIM BIOMEDICAL, INC. k000051 04/05/2000
acticoat 7 dressing WESTAIM BIOMEDICAL, INC. k001519 10/06/2000
bpc-3000 personal blood pressure communicator, model 52520 WELCH ALLYN, INC. k001543 01/29/2001
water purifier WATERCLAVE, L.L.C. k001878 08/03/2000
wako autokit lp(a)/dade demension WAKO CHEMICALS, USA, INC. k001919 07/23/2000
wako autokit lp(a)/ ra,500/1000, WAKO CHEMICALS, USA, INC. k001920 07/23/2000

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