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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 device for reduction of wound complications
510(k) Number K203716
Device Name PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System
Applicant
Smith and Nephew Medical Limited
101 Hessle Road
Hull,  GB HU3 2BN
Applicant Contact Steeve Lamvohee
Correspondent
Smith and Nephew Medical Limited
101 Hessle Road
Hull,  GB HU3 2BN
Correspondent Contact Steeve Lamvohee
Regulation Number878.4783
Classification Product Code
QFC  
Date Received12/21/2020
Decision Date 12/14/2021
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
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