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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 K221637
Device Name Surgical Gown (Sterile); Surgical Gown (Non-sterile)
Applicant
Allmed Medical (Hubei) Protective Products Co., Ltd
No.29 Dong Hu Road, Majiadian Town
Zhijiang,  CN 443203
Applicant Contact Vince Tian
Correspondent
Shanghai SUNGO Management Consulting Company Limited.
14th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/06/2022
Decision Date 09/29/2022
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
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