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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K200821
Device Name anti-bacterial bandage
Applicant
Planet (Suzhou) Medical Products Co., Ltd.
# 33 Qinglian Rd. Xuguan Industrial Park, Hi-Tech
Development Zone, Suzhou
Suzhou,  CN 215151
Applicant Contact Frank Zhou
Correspondent
Linkhope Medical Technology, Inc.
#231 Science Ave. Huangpu District, Guangzhou
Guangzhou,  CN 510700
Correspondent Contact Van Lee
Classification Product Code
FRO  
Date Received03/30/2020
Decision Date 10/19/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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