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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Perfusion, Kidney, Disposable
510(k) Number K091656
Device Name SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
Applicant
Organ Recovery Systems, Inc.
2570 E. Devon Ave.
Des Plaines,  IL  60018
Applicant Contact PJ PARDO
Correspondent
Organ Recovery Systems, Inc.
2570 E. Devon Ave.
Des Plaines,  IL  60018
Correspondent Contact PJ PARDO
Regulation Number876.5880
Classification Product Code
KDL  
Date Received06/09/2009
Decision Date 03/11/2010
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
Recalls CDRH Recalls
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