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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 K142916
Device Name SVED Wound Treatment System
Applicant
CARDINAL HEALTH
1500 S Waukegan Rd
Waukegan,  IL  60085
Applicant Contact Tatyana Bogdan
Correspondent
Navigant Consulting, Inc
9001 Wesleyan Road, Suite 200
Indianapolis,  IN  46268
Correspondent Contact Allison Scott, RAC
Regulation Number878.4780
Classification Product Code
OMP  
Date Received10/07/2014
Decision Date 03/04/2015
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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