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U.S. Department of Health and Human Services

510(K) Premarket Notification

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15.5 fr decathlon gold, funnel tips, coated hemodialysis catheter, dfc19sh24, dfc23sh28, dfc27sh32, dfc31sh36, dfc35sh40 SPIRE BIOMEDICAL INC k063431 01/29/2007
2-piece post and core for the b.a.s.i.c. dental implant system BASIC DENTAL IMPLANT SYSTEMS, INC. k001259 01/12/2001
3d humeral heads SMITH & NEPHEW, INC. k012378 12/13/2001
abbott architect estradiol calibrators; abbott imx estradiol calibrator; abbott imx estradiol mode 1 calibrator; abbott ABBOTT LABORATORIES k032458 10/06/2003
abbott imx glycated hemoglobin ii ABBOTT LABORATORIES k992085 05/25/2000
abca gas isotope ratio mass spectrometer systems PDZ-EUROPA LTD. k992163 07/13/1999
absorbent antimicrobial wound dressing CONVATEC, A DIVISION OF E.R. SQUIBB & SONS k013814 06/21/2002
accu-stat home drug test for marijuana, cocaine, amphetamine, methamphetamine, opiates, and phencyclidine ACCU-STAT DIAGNOSTICS, INC. k040629 05/05/2004
accuclot drvvt screen, catalog no. a6094 SIGMA DIAGNOSTICS, INC. k000527 04/07/2000
accuvix xq diagnostic ultrasound system MEDISON CO., LTD. k052911 10/31/2005

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