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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
Date
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rapidfire self drilling screws WALTER LORENZ SURGICAL, INC. k031751 06/26/2003
ts3 tubing set GLOBAL BLOOD RESOURCES, LLC k031151 06/26/2003
atb all-terrain balloon pta dilatation catheter COOK, INC. k031766 06/26/2003
ya mei first aid kit YA MEI TECHNOLOGY CO., LTD. k031130 06/27/2003
solo-care plus multipurpose solution CIBA VISION CORPORATION k031522 06/27/2003
endovive initial placement peg kit, direct pej kit, and peg safety kit BOSTON SCIENTIFIC CORP. k031538 06/27/2003
aosept clear care cleaning and disinfecting solution CIBA VISION CORPORATION k031521 06/27/2003
rusch polyflex stent for the esophagus w/introducer/delivery system RUSCH INTL. k030559 06/30/2003
asap cystoscope; asap laparoscope; asap larygoscope; asap oesophagoscope ASAP ENDOSCOPIC PRODUCTS GMBH k031141 06/30/2003
flexiskin powder free latex examination gloves, non sterile PT. MANDIRI INTI BUANA k031754 06/30/2003

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