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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 K251177
Device Name Self-Seal Sterilization Pouch and Roll
Applicant
Guangdong Maidi Medical Co., Ltd.
#3, Zhihui Rd., Guangzhou (Qingyuan)
Industrial Transfer Industrial Park, Shijiao Town, Qingyuan
Guangdong,  CN 511545
Applicant Contact Shi Xiong
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received04/16/2025
Decision Date 12/12/2025
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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