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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 K181929
Device Name MiMo(TM) Negative Pressure Wound Therapy System
Applicant
Baymax Research, Inc.
315 W36th St.
New York,  NY  10018
Applicant Contact Richard Chen
Correspondent
Baymax Research, Inc.
315 W36th St.
New York,  NY  10018
Correspondent Contact Richard Chen
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/18/2018
Decision Date 03/27/2019
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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