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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Perfusion, Kidney
510(k) Number K191006
Device Name EasiSlush
Applicant
Bridge TO Life, Ltd.
128 Suber Rd. Suite A
Columbia,  SC  29210
Applicant Contact Tom Keller
Correspondent
The Wood Burditt Group
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Correspondent Contact Richard O. Wood
Regulation Number876.5880
Classification Product Code
KDN  
Date Received04/16/2019
Decision Date 09/24/2019
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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