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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K241095
Device Name ARTSMedia Semen Wash Medium
Applicant
Artsmedia Denmark Aps
Kongevejen 149
Virum,  DK 2830
Applicant Contact Tina Andersen
Correspondent
Artsmedia Denmark Aps
Kongevejen 149
Virum,  DK 2830
Correspondent Contact Tina Andersen
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/22/2024
Decision Date 12/18/2024
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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