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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 K211060
Device Name Disposable Surgical Gown Rk-3011C
Applicant
Xiantao Rhycom Non-Woven Products Co., Ltd.
Chuangye Rd., Longhuashan Sub-District,
Xiantao,  CN
Applicant Contact Liu Yang
Correspondent
Purevisionai, Inc.
111 Town Square Place, Suite 1203
Jersey City,  NJ  07310 -2784
Correspondent Contact Bryan Wong
Regulation Number878.4040
Classification Product Code
FYA  
Date Received04/09/2021
Decision Date 10/28/2022
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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