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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 K251646
Device Name extriCARE® 1000 Negative Pressure Wound Therapy System
Applicant
Alleva Medical Devices
1050 W Central Ave.
Unit B
Brea,  CA  92821
Applicant Contact Max Choi
Correspondent
Addwin Consulting
13260 Middleton Farm Ln.
Herndon,  VA  20171
Correspondent Contact Mona Advani
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/29/2025
Decision Date 10/03/2025
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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