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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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Decision
Date
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mammosite radiation therapy system (rts) tray, mammosite hdr afterloader accessories tray PROXIMA THERAPEUTICS, INC. k030558 05/21/2003
rusch polyflex stent for the esophagus w/introducer/delivery system RUSCH INTL. k030559 06/30/2003
powderfree latex examination gloves with grape PT. SHAMROCK MANUFACTURING CORP. k030560 03/21/2003
mytech/happy life blood pressure monitor, models hpl-100 and hpl-100a MYTECH TECHNOLOGY CO., LTD. k030561 05/09/2003
tuohy epidural needle EPIMED INTERNATIONAL, INC. k030562 04/03/2003
arabella ncpap masks HAMILTON MEDICAL AG k030563 09/09/2003
thermoskin conductive pads UNITED PACIFIC, INC. k030564 09/12/2003
linical protein 3 calibration verifiers levels a-e for the olympus au series chemistry immuno analyzers CLINIQA CORPORATION k030566 03/13/2003
modification to vascular architects aspire covered stent and contrilled expansion delivery system VASCULAR ARCHITECTS, INC. k030567 03/24/2003
radii SOUTHERN DENTAL INDUSTRIES, INC. k030568 04/24/2003

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