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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 K223117
Device Name V-SPERM WASH
Applicant
Vitromed GmbH
Raiffeisenstr. 15a
Langenfeld,  DE 40764
Applicant Contact Greg Holland
Correspondent
Regulatory Specialists, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact Greg Holland
Regulation Number884.6180
Classification Product Code
MQL  
Date Received10/03/2022
Decision Date 01/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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