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U.S. Department of Health and Human Services

510(K) Premarket Notification

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161 to 170 of 498 Results
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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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pulsed light therapy system, model prima New Star Lasers, Inc. k041323 11/17/2004
compression anastomosis clip (cac) Niti Medical Technologies , Ltd. k041751 09/16/2004
accunet embolic protection system, rx accunet embolic protection system Guidant Corp. k042218 08/31/2004
ngdi (next generation diagnostic instrument) Bausch & Lomb k040913 07/23/2004
accu-stat home drug test cup for maijuanna (thc), cocaine (coc), amphetamine (amp), methamphetamine (mamp), ecstasy Accu-Stat Diagnostics, Inc. k041221 07/13/2004
aeskulisa cardiolipin agm Aesku, Inc. k040463 05/12/2004
safetynet guidewire introducer Injectimed, Inc. k040029 04/05/2004
k-y brand warming jelly personal lubricant Personal Products Company, Div. of Mcneil-Ppc, Inc. k040164 04/05/2004
x-view Sometech Corporation k024186 04/01/2004
microstat pva foam embolization particles Surgica Corp. k032619 02/13/2004

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