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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 K223600
Device Name Sterilization Wrap
Applicant
Wuhan Zonsen Medical Products Co., Ltd.
No 8 Jinchao Rd., Zhucheng St.
Wuhan,  CN
Applicant Contact Linna Ye
Correspondent
Wuhan Zonsen Medical Products Co., Ltd.
No 8 Jinchao Rd., Zhucheng St.
Wuhan,  CN
Correspondent Contact Linna Ye
Regulation Number880.6850
Classification Product Code
FRG  
Date Received12/02/2022
Decision Date 08/25/2023
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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