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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K243179
Device Name Sterilization Pouch and Roll
Applicant
Yichang Xinxin Paper Products Co., Ltd.
# 308, Jianghan Ave., Majiadian St., Zhijiang City
Yichang City,  CN 443200
Applicant Contact Xiao Peng
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received09/30/2024
Decision Date 06/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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