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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 K150960
Device Name WoundPro Negative Pressure Wound Therapy System
Applicant
Pensar Medical, LLC
42225 Remington Rd.
Temecula,  CA  92590
Applicant Contact BRIAN GUTHRIE
Correspondent
Pensar Medical, LLC
Paladin Medical, Inc
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number878.4780
Classification Product Code
OMP  
Date Received04/10/2015
Decision Date 12/01/2016
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 Yes
Predetermined Change
Control Plan Authorized		 No
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