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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 K053552
Device Name GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
Original Applicant
INTL., INC.
393 soundview rd.
guilford,  CT  06437
Original Contact michael d cecchi
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/21/2005
Decision Date 05/19/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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