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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 K220435
Device Name SEJONG Surgical Gown Soft
Applicant
Sejong Healthcare Co., Ltd.
1502-1, Tongil-Ro, Paju-Eup, Paju-Si, Gyeonggi-Do
Paju –Si,  KR 10836
Applicant Contact Bong Sung Lee
Correspondent
K-Bio Solutions
201 S. 4th St., Suite 727
San Jose,  CA  95112
Correspondent Contact Seohee Kwon
Regulation Number878.4040
Classification Product Code
FYA  
Date Received02/14/2022
Decision Date 02/10/2023
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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