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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 K161410
Device Name VT·One, VT·One 60days
Applicant
Carilex Medical, Inc.
# 77 Keji 1st Rd., Guishan Dist.
Taoyuan City,  TW 333
Applicant Contact Henry Kao
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact Maria Griffin
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/20/2016
Decision Date 10/13/2016
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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