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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K183602
Device Name SwimCount Sperm Quality Test
Applicant
Motilitycount Aps
G1. Koge Landevej 55
Valby,  DK DK-2500
Applicant Contact Jacob Mollenbach
Correspondent
Motilitycount Aps
G1. Koge Landevej 55
Valby,  DK DK-2500
Correspondent Contact Jacob Mollenbach
Regulation Number864.5220
Classification Product Code
POV  
Date Received12/26/2018
Decision Date 06/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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