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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K222999
Device Name Surgical Gown
Applicant
Hubei Woozon Healthcare Co., Ltd.
Nongfeng Rd., Nonwoven Fabric Industrial Park,
Wangzhou Ave., Pengchang Town
Xiantao City,  CN 433018
Applicant Contact Li Chunlin
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 Lujiazui E. Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/28/2022
Decision Date 06/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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