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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Extracellular Fluid, Lymphedema, Extremity
510(k) Number K143310
Device Name MoisturemeterD
Applicant
Delfin Technologies, Ltd.
Microkatu 1
Kuopio,  FI 70210
Applicant Contact Theodore Sullivan
Correspondent
Buchanan Ingersol and Rooney
1700 K St., NW, Suite 300
Washington,  DC  20006
Correspondent Contact Theodore Sullivan
Regulation Number870.2770
Classification Product Code
OBH  
Date Received11/18/2014
Decision Date 11/19/2015
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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