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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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bio-modular shoulder system BIOMET, INC. k992119 09/13/1999
samsung raypax long term archive SAMSUNG SDS CO., LTD k992131 09/13/1999
cortical mapping unit, model cmu AD-TECH MEDICAL INSTRUMENT CORP. k992194 09/13/1999
premier anterior cervical plate system SOFAMOR DANEK USA k992110 09/14/1999
dash siliconized polymer coated powder free latex examination gloves with protein content labeling claim (50 micrograms DASH MEDICAL GLOVES SDN BHD k992128 09/14/1999
coated sterile latex powder-free surgical gloves with protein content labeling claim (50 micrograms or less) ALLEGIANCE HEALTHCARE CORP. k992171 09/14/1999
bolus accessory set I-FLOW CORP. k992072 09/15/1999
nac prn needleless access connector THE KIPP GROUP k992268 09/15/1999
modification to pasco mic and mic/id panels (clindamycin) PASCO LABORATORIES, INC. k992143 09/16/1999
giltech plus hydrogel skin dressing GILTECH PLUS, INC. k992094 09/17/1999

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