FDA 510(k) Application Details - K170797

Device Classification Name Lubricant, Patient, Vaginal, Latex Compatible

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510(K) Number K170797
Device Name Lubricant, Patient, Vaginal, Latex Compatible
Applicant Wettrust Korea Co., Ltd.
312 The Prau, 27 Jeongjail-ro, Bundang-gu
Seongnam 463-480 KR
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Contact Sungho Lee
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Regulation Number 884.5300

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Classification Product Code NUC
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Date Received 03/17/2017
Decision Date 12/06/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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