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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K233428
Device Name Easycess Aspiration Pump
Applicant
Guangzhou Easycess Medical Co., Ltd
Room 701, Building B4, 11 Kaiyuan Avenue, Huangpu District,
Huangpu District,
Guangzhou,  CN 510530
Applicant Contact Xingcheng Liu
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4780
Classification Product Code
JCX  
Date Received10/11/2023
Decision Date 11/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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