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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 K220665
Device Name Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
Applicant
Excellent Medical Technology Group Co., Ltd.
Rm.# 2301, Decheng Jiayuan Plz., # 1539 Xiangcheng Rd.
Suzhou,  CN 215131
Applicant Contact Kenney Song
Correspondent
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Bldg., #26 Qinglan St., Panyu
District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number878.4040
Classification Product Code
FYA  
Date Received03/07/2022
Decision Date 06/03/2022
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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