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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K213906
Device Name extriCARE 1000 Negative Pressure Wound Therapy System
Applicant
Alleva Medical, Ltd.
Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan St.
Shek Mun,  HK
Applicant Contact Max Choi
Correspondent
Alleva Medical, Ltd.
Suite M-Q, 12th Floor, Kings Wing Plaza 2, 1 On Kwan St.
Shek Mun,  HK
Correspondent Contact Max Choi
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/14/2021
Decision Date 03/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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