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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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digital integration system, dis2000 WELLINGTON MEDICAL SYSTEMS, INC. k001012 06/13/2000
digitimer d185 multipulse cortical stimulator MEPS, LLC. k020400 08/23/2002
discovery elbow BIOMET ORTHOPEDICS, INC. k013042 10/10/2001
disposable injector or disposable sclerotherapy needle ENTERIC MEDICAL TECHNOLOGIES k000646 04/13/2000
distal radius plating system BIOMET, INC. k020819 04/22/2002
drg aurica elisa testosterone kit DRG INTL., INC. k000043 04/17/2000
dual energy and tissue equalization software option GE MEDICAL SYSTEMS k013481 11/02/2001
duracon cs tibial insert HOWMEDICA OSTEONICS CORP. k021451 10/18/2002
dynapulse 5200a pathway blood pressure monitoring system PULSE METRIC, INC. k013478 01/10/2002
echo-screen t, ta, td, tda, tc FISCHER-ZOTH AUDIOLOGIC SYSTEMS, INC. k013977 06/14/2002

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