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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 K180614
Device Name PICO Single Use Negative Pressure Wound Therapy System
Applicant
Smith & Nephew Medical Limited
101 Hessle Road
Hull,  GB HU3 2BN
Applicant Contact Lavinia Tompkins
Correspondent
Smith & Nephew
7000 West William Cannon Drive
Austin,  TX  78735
Correspondent Contact Kulsum Master
Regulation Number878.4780
Classification Product Code
OMP  
Date Received03/08/2018
Decision Date 04/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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