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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 K850979
Device Name HEMOCONCENTRATOR KIT
Applicant
Omnis Surgical, Inc.
1 Baxter Pkwy. 3-2w
Deerfield,  IL  60015
Applicant Contact THOMAS D NICKEL
Correspondent
Omnis Surgical, Inc.
1 Baxter Pkwy. 3-2w
Deerfield,  IL  60015
Correspondent Contact THOMAS D NICKEL
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/08/1985
Decision Date 07/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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