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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K193444
Device Name Vagisan MoistCream Cremolum
Applicant
Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstrasse 56
Bielefeld,  DE D-33611
Applicant Contact Thomas Flototto
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Oliver Eikenberg
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/12/2019
Decision Date 12/04/2020
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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