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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 K964514
Device Name CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
Applicant
Corpak, Inc.
100 Chaddick Dr.
Wheeling,  IL  60090
Applicant Contact ROBERT E BOOTH
Correspondent
Corpak, Inc.
100 Chaddick Dr.
Wheeling,  IL  60090
Correspondent Contact ROBERT E BOOTH
Regulation Number876.5630
Classification Product Code
FKO  
Date Received10/29/1996
Decision Date 06/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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