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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 K143498
Device Name LifeGlobal Global HP
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 Received12/10/2014
Decision Date 01/20/2015
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
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