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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Culture, Ex Vivo, Tissue And Cell
510(k) Number K103302
Device Name STEMPRO MSC SFM
Applicant
Life Technologies Corporation
3175 Staley Rd.
Grand Island,  NY  14072
Applicant Contact KELLI TANZELLA
Correspondent
Life Technologies Corporation
3175 Staley Rd.
Grand Island,  NY  14072
Correspondent Contact KELLI TANZELLA
Regulation Number876.5885
Classification Product Code
NDS  
Date Received11/09/2010
Decision Date 02/18/2011
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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