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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 K151436
Device Name PICO Single Use Negative Pressure Wound Therapy System
Applicant
Smith & Nephew Medical, Ltd.
101 Hessle Rd.
Hull,  GB HU32BN
Applicant Contact SAMANTHA NEILSON
Correspondent
Smith & Nephew, Inc.
970 Lake Carillon Dr.
Suite 110
St Petersburg,  FL  33716
Correspondent Contact Samantha Neilson
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/28/2015
Decision Date 01/28/2016
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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