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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 K053646
Device Name INVITRO MATURATION MEDIA
Applicant
SAGE IN-VITRO FERTILIZATION INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
SAGE IN-VITRO FERTILIZATION INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/30/2005
Decision Date 07/14/2006
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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