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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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seragard injection patch PLATINUM SERVICES, INC. k001240 06/21/2000
dentalmatic ti prosthesis and dentalmatic ti-a prosthetic DENTALMATIC TECHNOLOGIES, INC. k001269 06/21/2000
calcium sulfate pellets HOWMEDICA OSTEONICS CORP. k001559 06/20/2000
advantage thc test ADVANTAGE DIAGNOSTICS CORP. k001567 06/19/2000
pbn hystero-salpingography catheter set MEDICAL DEVICE TECHNOLOGIES, INC. k000433 06/16/2000
ultrastim electrode, model us4040 AXELGAARD MFG. CO., LTD. k000947 06/16/2000
placer model 6232 steerable stylet MEDTRONIC VASCULAR k000955 06/16/2000
dyna-lok classic spinal system MEDTRONIC SOFAMOR DANEK, INC. k001532 06/16/2000
echocom, imagecom, dokucom TOMTEC IMAGING SYSTEMS, GMBH k001592 06/16/2000
pipet curet MILEX PRODUCTS, INC. k001545 06/15/2000

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