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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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infared ear thermometer, model th8 series RADIANT INNOVATION, INC. k011059 09/17/2001
surgical contra-angel handpieces types ws-56e,ws-75e/km,ws-92 e/3,surgical straight handpieces types, s-9, s-10, s-11 W & H DENTALWERK BUERMOOS GMBH k011061 06/28/2001
classic cem S & C POLYMER GMBH k011064 05/17/2001
intracorporeal ultrasound lithotripter, model 2271.004, ultrasound transducer, model 2271.501, ultrasound probes (sono) RICHARD WOLF MEDICAL INSTRUMENTS CORP. k011065 05/09/2001
sterile latex surgical gloves (powdered) with protein content labeling claim (100 micrograms or less) SMART GLOVE CORP. SDN BHD k011066 09/11/2001
modification to tsrh spinal system MEDTRONIC SOFAMOR DANEK, INC. k011067 05/04/2001
rhigene ndna test system for imagetiter, model cl100l RHIGENE, INC. k011068 04/11/2002
aquasens fluid monitoring system DAVOL, INC., SUB. C.R. BARD, INC. k011069 08/16/2001
drt4 laser doppler perfusion and temperature monitor MOOR INSTRUMENTS LTD. k011070 11/07/2001
paradigm quick-set infusion set MAERSK MEDICAL A/S k011071 06/07/2001

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