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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name microtools, assisted reproduction (pipettes)
510(k) Number K152581
Device Name LifeGlobal Micro Tips
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 Number884.6130
Classification Product Code
MQH  
Date Received09/10/2015
Decision Date 04/11/2016
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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