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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media, reproductive
510(K) Number K121572
Device Name CONTINUOUS SINGLE CULTURE COMPLETE
Applicant
IRVINE SCIENTIFIC SALES CO., INC.
2511 daimler st
santa ana,  CA  92705
Contact jayme yamaguchi-owens
Regulation Number884.6180
Classification Product Code
MQL  
Date Received05/29/2012
Decision Date 07/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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