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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal Dialysis, Single Use
510(k) Number K974570
Device Name PERITONEAL DIALYSIS CATHETER CONNECTOR
Applicant
Medigroup, Inc.
615 Enterprise St.
Aurora,  IL  60504 -8138
Applicant Contact JOHN NAVIS
Correspondent
Medigroup, Inc.
615 Enterprise St.
Aurora,  IL  60504 -8138
Correspondent Contact JOHN NAVIS
Regulation Number876.5630
Classification Product Code
FKO  
Date Received12/08/1997
Decision Date 02/27/1998
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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