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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 K213293
Device Name V-HEPES PLUS
Applicant
Vitromed Langenfeld
Raoffeosemstr 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 Received10/01/2021
Decision Date 09/14/2022
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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