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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 K233183
Device Name Surgical Gown (40083)
Applicant
Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.
Southern Industrial Zone (Xinlirenkou)
Xiantao,  CN 433011
Applicant Contact Melody Wang
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/28/2023
Decision Date 02/01/2024
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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