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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K222611
Device Name Male Latex Condoms
Applicant
Suzhou Colour-Way New Material Co., Ltd.
# 20 Anmin Rd., Huangdai Town, Xiangcheng District
Suzhou,  CN 215152
Applicant Contact Yongping Xu
Correspondent
Suzhou Colour-Way New Material Co., Ltd.
# 20 Anmin Rd., Huangdai Town, Xiangcheng District
Suzhou,  CN 215152
Correspondent Contact Ivy Wang
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/30/2022
Decision Date 11/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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