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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 K151326
Device Name RENASYS¿ EZ PLUS Negative Pressure Wound Therapy 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  
Date Received05/18/2015
Decision Date 07/16/2015
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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