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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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powder-free nitrile examination gloves with aloe vera, green (tested for use with chemotherapy drugs) SHEN WEI (USA), INC. k010097 03/30/2001
ppcid- pneumatic peripheral circulation improvement (footrest) device AHAVA STEIN k000655 03/26/2001
zenith plate system, anterior spinal instrumentation ORTHOTEC, L.L.C. k001535 03/20/2001
lactosorb 5.0 mm washer BIOMET, INC. k001581 03/20/2001
surshield winged infusion set TERUMO MEDICAL CORP. k010103 03/15/2001
sonicaid fm820, sonicaid fm830 OXFORD INSTRUMENTS k002150 03/09/2001
supercross catheter ABBOTT VASCULAR INC. k001856 03/07/2001
multi care therapeutic vibrator MULTICEPT A/S k010096 03/05/2001
transanal endoscopic microsurgery (tem) combination system and instrument set, instrument set for the transanal endoscop RICHARD WOLF MEDICAL INSTRUMENTS CORP. k000180 03/02/2001
fluoroperm 151-ok, paragon hds 100-ok PARAGON VISION SCIENCES k010109 02/28/2001

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