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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name labware, assisted reproduction
510(k) Number K162640
Device Name iVitri EZ
Applicant
REPROBITECH CORP.
27 HADDON RD
New Hyde Park,  NY  11040
Applicant Contact Huai L. Feng
Correspondent
REPROBITECH CORP.
42-31 Colden Street, Suite 202
Flushing,  NY  11355
Correspondent Contact Huai L. Feng
Regulation Number884.6160
Classification Product Code
MQK  
Date Received09/22/2016
Decision Date 06/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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