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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 K222480
Device Name Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)
Applicant
Foshan Nanhai Plus Medical Co, Ltd.
Shatou Jiujiang Town
Nanhai District
Foshan,  CN 5282000
Applicant Contact Eric Li
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
14f, Bldg. C, Ancillary Project Of Phase Iv Standard
Industrial Park Guangzhou International Bio-Island
Guangzhou,  CN 510320
Correspondent Contact Olivia Meng
Regulation Number878.4040
Classification Product Code
FYA  
Date Received08/17/2022
Decision Date 11/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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