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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 K210215
Device Name Surgical Gowns
Applicant
Jiangsu Province Jianerkang Medical Dressing Co., Ltd
No.1 Jianerkang Road, Zhixi Industry Concentration Area,
Zhixi Town
Changzhou,  CN 213251
Applicant Contact Tang Hongfang
Correspondent
Jiangsu Province Jianerkang Medical Dressing Co., Ltd
No.1 Jianerkang Road, Zhixi Industry Concentration Area,
Zhixi Town
Changzhou,  CN 213251
Correspondent Contact Tang Hongfang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received01/27/2021
Decision Date 07/07/2021
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
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