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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 K202667
Device Name Personal Lubricant Jelly
Applicant
Nantong Health & Beyond Hygienic Products, Inc.
# 118, Yuxian Rd., N. Town St.
Rugao,  CN 226575
Applicant Contact Michael Zhu
Correspondent
Nantong Health & Beyond Hygienic Products, Inc.
# 118, Yuxian Rd., N. Town St.
Rugao,  CN 226575
Correspondent Contact Michael Zhu
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/14/2020
Decision Date 05/18/2021
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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