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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
Applicant
<Genx> Intl., Inc.
393 Soundview Rd.
Gilford,  CT  06437
Applicant Contact MICHAEL D CECCHI
Correspondent
Intl., Inc.
393 Soundview Rd.
Gilford,  CT  06437
Correspondent Contact MICHAEL D CECCHI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received12/20/2005
Decision Date 05/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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