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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 K103220
Device Name VOYAGER PERITONEAL DIALYSIS 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 Received11/01/2010
Decision Date 07/29/2011
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
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