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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, For Peritoneal Dialysis, Disposable
510(k) Number K031676
Device Name HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
Applicant
Baxter Healthcare Corp
1620 Waukegan Rd., Mpr-A2e
Mcgaw Park,  IL  60085 -6730
Applicant Contact DAVID E CURTIN
Correspondent
Baxter Healthcare Corp
1620 Waukegan Rd., Mpr-A2e
Mcgaw Park,  IL  60085 -6730
Correspondent Contact DAVID E CURTIN
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received05/30/2003
Decision Date 11/20/2003
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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