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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K212422
Device Name Disposable Surgical Isolation Gown
Applicant
Crown Name Disposable Hygiene Products Fty., Ltd.
Chengbei Industrial Zone,Zhucheng Ave.,Xinzhou District
Wuhan,  CN 431400
Applicant Contact Ying Fang
Correspondent
Shanghai Jiushun Enterprise Management Technology Service Co
Rm. 1502, Baoan Buiding, #800 Dongfang Rd.
Shanghai,  CN 200122
Correspondent Contact Doris Chen
Regulation Number878.4040
Classification Product Code
FYC  
Date Received08/04/2021
Decision Date 04/29/2022
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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