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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K203415
Device Name Surgical Isolation Gown
Applicant
Yanbian Pacific Textile Co., Ltd.
Longjing Industry Concentration Area
Longjing,  CN 133400
Applicant Contact Juan Zhuang
Correspondent
Pacific Fortune Management, Inc.
2350 Mission College Blvd., Suite 475
Santa Clara,  CA  95054
Correspondent Contact Rafi Wong
Regulation Number878.4040
Classification Product Code
FYC  
Date Received11/19/2020
Decision Date 05/20/2021
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
Predetermined Change
Control Plan Authorized		 No
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