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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K970446
Device Name DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
Applicant
Althin Medical AB an Affiliate of Baxter Intl
13520 SE Pheasant Ct.
Portland,  OR  97222
Applicant Contact THOMAS D KELLY
Correspondent
Althin Medical AB an Affiliate of Baxter Intl
13520 SE Pheasant Ct.
Portland,  OR  97222
Correspondent Contact THOMAS D KELLY
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Codes
JPI   MQS  
Date Received02/05/1997
Decision Date 06/02/1997
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
Recalls CDRH Recalls
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