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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 K173407
Device Name VT - 100, VT - 200
Applicant
Carilex Medical, Inc.
# 77 Keji 1st Rd., Guishan Dist.
Taoyuan City,  TW 333
Applicant Contact Henry Kao
Correspondent
Carilex Medical, Inc.
# 77 Keji 1st Rd., Guishan Dist.
Taoyuan City,  TW 333
Correspondent Contact Henry Kao
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/01/2017
Decision Date 08/09/2018
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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