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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 EAST DEVON AVE
des plaines,  IL  60018 -4912
Applicant Contact pj pardo
Correspondent
ORGAN RECOVERY SYSTEMS, INC.
2570 EAST DEVON AVE
des plaines,  IL  60018 -4912
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
Recalls CDRH Recalls
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