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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 K173075
Device Name ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
Applicant
DxNow, Inc.
401 Professional Drive, Suite 130
Gaithersburg,  MD  20879 -3429
Applicant Contact William T. Sharp
Correspondent
DxNOW, INC
401 Professional Drive, Suite 130
Gaithersburg,  MD  20879 -3429
Correspondent Contact Kevin Sly
Regulation Number884.6160
Classification Product Code
MQK  
Date Received09/29/2017
Decision Date 03/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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