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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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endovascular guide wire STEREOTAXIS, INC. k021363 11/27/2002
epoca codr stem and head STELKAST COMPANY k014049 01/09/2002
epy-50 DDC TECHNOLOGIES, INC. k020513 05/16/2002
equalizer balloon catheter BOSTON SCIENTIFIC CORP. k021721 06/20/2002
escreen system ESCREEN, INC. k003352 03/20/2001
esthetic ease abutments for the iti dental implant system INSTITUT STRAUMANN AG k020096 02/08/2002
ethanol ABBOTT LABORATORIES k013538 12/14/2001
evans sub-q, model mc4206 EVANS MEDICAL, INC. k020530 04/29/2002
exel vaculet blood collection set EXELINT INTL. CO. k020533 12/02/2002
exhale probe BRONCUS TECHNOLOGIES, INC. k013111 10/01/2001

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