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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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constellation vision system ALCON RESEARCH, LTD. k141065 08/22/2014
contro ii HI CHEM, INC. k791696 09/24/1979
controller, servo, inspiron C.R. BARD, INC. k780630 05/31/1978
copal knee moulds Heraeus Medical GmbH k222570 02/04/2023
cosmatrix TEI BIOSCIENCES INC. k060829 05/17/2006
cpk-l tube BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC k781149 08/14/1978
crc 15ultra CAPINTEC, INC. k052595 11/08/2005
crosscountry transbronchial access tool straight, crosscountry transbronchial access tool curved COVIDIEN k142934 06/17/2015
cytotran i bone marrow aspiration system APPLIED MEDICAL DEVICES, INC. k802406 01/15/1981
d101 kids infant hollow fiber membrane oxygenator with integrated hardshell cardiotomy/venous reservoir SORIN GROUP ITALIA S.R.L. k072091 10/29/2007

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