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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 K124018
Device Name AMIA AUTOMATED PD SYSTEM
Applicant
DEKA RESEARCH & DEVELOPMENT CORP.
340 COMMERCIAL ST.
MANCHESTER,  NH  03101
Applicant Contact ROGER A LEROUX
Correspondent
DEKA RESEARCH & DEVELOPMENT CORP.
340 COMMERCIAL ST.
MANCHESTER,  NH  03101
Correspondent Contact ROGER A LEROUX
Regulation Number876.5630
Classification Product Code
FKX  
Date Received12/27/2012
Decision Date 06/14/2013
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
Recalls CDRH Recalls
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