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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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automated workcell control software LAB-INTERLINK, INC. k010500 08/01/2001
vivo 200 dps vivoscan VIVOSONIC, INC. k003364 07/18/2001
ha-ti (hand titanium screw) implant HATI DENTAL AG. k003045 07/12/2001
immulite intact pth, model lkpp1 (100 tests), lkpp5 (500 tests), immulite 2000 intact pth, model l2kpp (200 tests), l2k6 DIAGNOSTIC PRODUCTS CORP. k011505 07/02/2001
embogold microsphere BIOSPHERE MEDICAL, INC. k010026 06/21/2001
pfc sigma lugged tibial tray DEPUY ORTHOPAEDICS, INC. k003026 06/19/2001
eeg mis monitor model # a-2000; bis engine ASPECT MEDICAL SYSTEMS, INC. k011534 06/15/2001
memodyn staple TELOS MEDICAL EQUIPMENT k002695 06/13/2001
sigma delta PENLON LTD. k002343 06/08/2001
clarren helmet CHILDREN'S HOSPITAL & MEDICAL CENTER k003035 06/06/2001

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