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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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oxygen supply tubing, model 1115 HUDSON RESPIRATORY CARE, INC. k011134 06/13/2001
gsi audera NICOLET BIOMEDICAL k011135 07/26/2001
apex fixation pins HOWMEDICA OSTEONICS CORP. k011136 05/04/2001
resorbable hammertoe pin BIOMET, INC. k011137 06/19/2001
bilateral fitting of the branemark bone-anchored hearing aid (baha) system. ENTIFIC MEDICAL SYSTEMS, INC. k011438 07/23/2001
modification to bioz.com hemodynamic monitor CARDIODYNAMICS INTERNATIONAL CORP. k011439 11/02/2001
jas calcium (arsenazo) reagent JAS Diagnostics, Inc. k011441 07/09/2001
abbott plum a+infusion pump, model 11971 ABBOTT LABORATORIES k011442 06/05/2001
threaded cement restrictor (cr) titanium MEDTRONIC SOFAMOR DANEK USA, INC. k011443 08/03/2001
anspach emax drill system THE ANSPACH EFFORT, INC. k011444 08/08/2001

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