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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 K142991
Device Name LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
Applicant
LifeGlobal Group, LLC
393 Soundview Road
Guilford,  CT  06437
Applicant Contact Michael D. Cecchi
Correspondent
LifeGlobal Group, LLC
393 Soundview Road
Guilford,  CT  06437
Correspondent Contact Michael D. Cecchi
Regulation Number884.6180
Classification Product Code
MQL  
Date Received10/16/2014
Decision Date 02/17/2015
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
Recalls CDRH Recalls
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