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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 K211318
Device Name PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
Applicant
Smith Nephew Medical Limited
101 Hessle Rd.
Hull,  GB HU3 2Bn
Applicant Contact Steeve Lamvohee
Correspondent
Smith Nephew Medical Limited
101 Hessle Rd.
Hull,  GB HU3 2Bn
Correspondent Contact Steeve Lamvohee
Regulation Number878.4780
Classification Product Code
OMP  
Date Received04/30/2021
Decision Date 01/05/2022
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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