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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 K121128
Device Name MULTIPURPOSE HANDLING MEDIUM
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 Received04/13/2012
Decision Date 06/06/2012
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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