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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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advia ims BAYER CORP. k001344 06/26/2000
guidant retriever device GUIDANT CARDIAC AND VASCULAR SURGERY k001694 05/15/2001
rigid gas permeable contact lens POLYMER TECHNOLOGY k002025 10/31/2000
baylis pain management probe/pmp-20-145 and baylis pain management connector cable/pmx-bay-bay BAYLIS MEDICAL CO., INC. k002389 10/23/2000
equity JENSEN INDUSTRIES, INC. k002826 10/24/2000
pediatric ingestascan ADAMS ELECTRONICS, INC. k003305 12/22/2000
st. francis operating theatre lamp, models olh01-125 and lc-055 ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. k003423 02/22/2001
focus dailies progressives CIBA VISION CORPORATION k003826 03/08/2001
inflatable penile prosth. - cylinder AMERICAN MEDICAL SYSTEMS, INC. k830048 04/12/1983
franzen needle guide PRECISION DYNAMICS CORP. k830235 02/23/1983

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