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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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ldh reagent for demand analyzer Advanced Biomedical Methods, Inc. k850378 03/01/1985
3 x 4 non-adherent pad American White Cross, Inc. k850595 03/11/1985
howmedica threaded acetabular component Pfizer, Inc. k850840 07/15/1985
implantable program-cardiac pulse gen-optima mp ii Telectronics, Inc. k851081 04/04/1985
randall kidney stone forceps 817-144 pcs. full cur The Huxley Instrument Corp. k851113 04/03/1985
microstatic urine transport tube for c & s Analytical Luminescence Laboratory, Inc. k851387 05/20/1985
spectrum 150 dt Raytheon Medical Systems k851644 05/21/1985
prefer incontinence aid Rocky Mountain Medical Corp. k851876 06/12/1985
pb900 pb910 diagnostic spirometer Puritan Bennett Corp. k852092 07/30/1985
unistim unt-1 Neuromed, Inc. k852326 11/14/1985

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