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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 K241348
Device Name SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
Applicant
Motilitycount Aps
Gl. Køge Landevej 57, 2
Valby,  DK DK-2500
Applicant Contact Jacob Møllenbach
Correspondent
Motilitycount Aps
Gl. Køge Landevej 57, 2
Valby,  DK DK-2500
Correspondent Contact Jacob Møllenbach
Regulation Number884.6160
Classification Product Code
MQK  
Date Received05/13/2024
Decision Date 01/31/2025
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
Predetermined Change
Control Plan Authorized		 No
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