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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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etest meropenem AB BIODISK k010363 04/09/2001
mcc-miv one 2 one software INVACARE CORP. k010364 03/22/2001
ortho control female urinary control device PERSONAL PRODUCTS CO. k010365 04/30/2001
disposable storage cap MOLDED PRODUCTS INC. k010366 11/28/2001
modification to titanium tri-lock hips stem DEPUY ORTHOPAEDICS, INC. k010367 03/09/2001
claris plate system ORTHOTEC, L.L.C. k010369 05/08/2001
lifestyles, contempo or private label, male latex condom with glycerine lubricant SURETEX, LTD. k010371 04/27/2001
lightlas 532 photocoagulator LIGHTMED CORP. k010372 08/22/2001
simplicity soft y infusion set for use with the minimed infusion pumps and minimed medication reservoirs (model mmt-103) STERLING MEDIVATIONS, INC. k010373 03/13/2001
sonosite hand-carried ultrasound system SONOSITE,INC. k010374 02/21/2001

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