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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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randox c-reactive protein Randox Laboratories, Ltd. k001009 08/04/2000
sysmex automated coagulation analyzer, model ca-1500 Dade Behring, Inc. k001645 08/04/2000
tampons Rostam , Ltd. k001641 08/03/2000
chase cardiovascular patch Chase Medical, Inc. k001662 08/02/2000
ksea bipolar coagulating electrodes Karl Storz Endoscopy k001630 07/19/2000
compact portable patient monitor with wireless alan, model alilent m3000a/m3046a option j120 Agilent Technologies, Inc. k001664 06/30/2000
disposable powder free nitrile exam glove, green color Sheen More Ent. Co., Ltd. k001637 06/23/2000
biosoft resin Biosoft International Corp. k001640 06/23/2000
varis 1.4g Varian Medical Systems, Inc. k001643 06/23/2000
steritec autoclave tapes, model ci122 & ci1234 Steritec Products, Inc. k001649 06/23/2000

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