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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 K143133
Device Name RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
Applicant
SMITH & NEPHEW, INC.
970 LAKE CARILLON DRIVE
SUITE 110
ST. PETERSBURG,  FL  33716
Applicant Contact LAURA REYNOLDS
Correspondent
SMITH & NEPHEW, INC.
970 LAKE CARILLON DRIVE
SUITE 110
ST. PETERSBURG,  FL  33716
Correspondent Contact LAURA REYNOLDS
Regulation Number878.4780
Classification Product Code
OMP  
Subsequent Product Code
FTL  
Date Received10/31/2014
Decision Date 07/23/2015
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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