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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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imagyn isosleeve / isostar needle system Imagyn Medical Technologies, Inc. k010166 12/03/2001
bard utraverse small vessel pta balloon dilatation catheter C.R Bard, Inc. k010169 02/13/2001
trident porous titanium acetabular component Howmedica Osteonics Corp. k010170 04/18/2001
duraloc acetabular cup system, 36mm marathon +4 polyethylene liner Depuy Orthopaedics, Inc. k010171 04/06/2001
lead blocks Arplay Medical S.A. k010172 04/18/2001
ultrafree max sterile latex poweder-free surgical gloves with protein labeling claim, 50 per gram or less of total water Allegiance Healthcare Corp. k010862 06/07/2001
laglove brand nitroprene powder free examination gloves (made of nitrile-neoprene co-polymer) La Glove (M) Sdn. Bhd. k010863 05/03/2001
analyst panels + analytical test rotor Hemagen Diagnostics, Inc. k010864 05/21/2001
amsco century medium sterilizer, model century Steris Corporation k010865 05/31/2001
temp-a-sure Homecare Technologies , Ltd. k010866 06/06/2001

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