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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 K080650
Device Name OMNI-DL SYSTEM
Applicant
Transvivo, Inc.
3067 Research Dr.
Richmond,  CA  94806
Applicant Contact J. MICHAEL DELMAGE
Correspondent
Transvivo, Inc.
3067 Research Dr.
Richmond,  CA  94806
Correspondent Contact J. MICHAEL DELMAGE
Regulation Number876.5860
Classification Product Code
KDI  
Date Received03/07/2008
Decision Date 11/26/2008
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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