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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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placer model 6232 steerable stylet Medtronic Vascular k000955 06/16/2000
phoresor model pm2000 Iomed, Inc. k001410 08/01/2000
philips easy vision family workstation option mr quantitative flow Philips Medical Systems North America, Inc. k003459 01/22/2001
phd personal hemodialysis instrument-1m101, phd water pre-treatment kit-1w605,phd hard plumbing kit-1w604, phd blood tub Aksys, Ltd. k010131 03/26/2002
penadapt 10 Buffalo Filter Co., Inc. k000904 06/08/2000
pbn hystero-salpingography catheter set Medical Device Technologies, Inc. k000433 06/16/2000
patient latex polymer coated powder-free gloves, contains 50 microgram or less of total water extractable protein per gr Comfort Rubber Gloves Industries Sdn. Bhd. k002065 08/22/2000
pasteur pipet - sterile 9, pasteur pipet - sterile 5 3/4, models 16-pp-9, 16-pp-5.75 Humagen Fertility Diagnostics, Inc. k000915 05/12/2000
paragon cze 2000 capillary electrophoresis system and buffer-100 Beckman Coulter, Inc. k002799 10/05/2000
para 12 plus retics Streck Laboratories, Inc. k000945 04/18/2000

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