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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
Applicant Contact JAYME YAMAGUCHI-OWENS
Correspondent
IRVINE SCIENTIFIC SALES CO., INC.
2511 DAIMLER ST
SANTA ANA,  CA  92705
Correspondent Contact JAYME YAMAGUCHI-OWENS
Regulation Number884.6180
Classification Product Code
MQL  
Date Received05/29/2012
Decision Date 07/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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