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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 K092667
Device Name GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
Applicant
Genx Intl., Inc.
393 Soundview Rd.
Gilford,  CT  06437
Applicant Contact MICHAEL D CECCHI
Correspondent
Genx Intl., Inc.
393 Soundview Rd.
Gilford,  CT  06437
Correspondent Contact MICHAEL D CECCHI
Regulation Number884.6180
Classification Product Code
MQL  
Date Received08/31/2009
Decision Date 06/03/2010
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 Yes
Predetermined Change
Control Plan Authorized		 No
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