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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 K170797
Device Name wettrust D2care
Applicant
Wettrust Korea Co., Ltd.
312 The Prau, 27 Jeongjail-ro, Bundang-gu
Seongnam,  KR 463-480
Applicant Contact Sungho Lee
Correspondent
mdi Consultant, Inc.
55 Northern Blvd
Great Neck,  NY  11021
Correspondent Contact Jigar Shah
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/17/2017
Decision Date 12/06/2017
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
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