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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Autonomous Extracorporeal Blood Leak Detector/Alarm
510(k) Number K092955
Device Name REDSENSE-HOME USE
Applicant
Redsense Medical AB
435 Rice Creek Terrance
Fridley,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Redsense Medical AB
435 Rice Creek Terrance
Fridley,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number876.5820
Classification Product Code
ODX  
Date Received09/25/2009
Decision Date 05/10/2010
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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