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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 K250964
Device Name Protable Phlegm Suction Unit (JMA D01)
Applicant
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
#36 Danyan Rd.
Danyang,  CN 212300
Applicant Contact Yao Yu
Correspondent
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
#36 Danyan Rd.
Danyang,  CN 212300
Correspondent Contact Yao Yu
Regulation Number878.4780
Classification Product Code
JCX  
Date Received03/31/2025
Decision Date 05/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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