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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Body Composition
510(k) Number K122388
Device Name SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
Applicant
SECA GMBH & CO. KG
1300 I STREET, NW, 11TH FLOOR EAST
WASHINGTON,  DC  20005 -3314
Applicant Contact SETH A MAILHOT
Correspondent
SECA GMBH & CO. KG
1300 I STREET, NW, 11TH FLOOR EAST
WASHINGTON,  DC  20005 -3314
Correspondent Contact SETH A MAILHOT
Regulation Number870.2770
Classification Product Code
MNW  
Date Received08/06/2012
Decision Date 05/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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