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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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orthadapt bioimplant PEGASUS BIOLOGICS, INC. k071065 05/04/2007
clirpath turbo excimer laser catheter (rx) -0.9mm, (rx) -1.4mm, (rx) -1.7mm, (rx) -2.0mm, model 310-154, 314-159, 317-15 SPECTRANETICS CORP. k071227 07/11/2007
echoview / shimasonic diagnostic ultrasound system, model sdu-1100 SHIMADZU MEDICAL SYSTEMS k071291 01/09/2008
endoscopic plication system; eps; plicator NDO SURGICAL, INC. k071553 09/18/2007
aquadex flexflow system CHF SOLUTIONS, INC. k071854 09/07/2007
exactrac 3rd party, exactrac x-ray 6d 3rd party, exactrac oem BRAINLAB AG k072046 10/17/2007
skintact multifunctional electrodes with dh02 gel with different connectors compatible with different defibrillators LEONHARD LANG GMBH k072233 10/05/2007
ge lunar dpx & prodigy series dexa bone densitometers with mobile kit GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA k072439 09/14/2007
unicryl quick UNITED MEDICAL INDUSTRIES CO. LTD. k072644 11/07/2007
sequoia spinal system, model 3300 series ABBOTT SPINE, INC. k072672 11/28/2007

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