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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 K251347
Device Name Sterilization Pouch/Roll
Applicant
Sterivic Medical Co., Ltd.
Dadukou Economic Development Zone
Chizhou,  CN 247210
Applicant Contact Wanggen Jiang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
JOJ  
Date Received04/30/2025
Decision Date 01/28/2026
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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