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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Peritoneal, Automatic Delivery
510(k) Number K151525
Device Name Amia Automated PD System with Sharesource
Applicant
DEKA RESEARCH AND DEVELOPMENT
340 COMMERCIAL ST.
MANCHESTER,  NH  03101
Applicant Contact ROGER LEROUX
Correspondent
DEKA RESEARCH AND DEVELOPMENT
340 COMMERCIAL ST.
MANCHESTER,  NH  03101
Correspondent Contact ROGER LEROUX
Regulation Number876.5630
Classification Product Code
FKX  
Date Received06/08/2015
Decision Date 10/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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