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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 K143016
Device Name Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
Applicant
Cardinalhealth
1500 S Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact Tatyana Bogdan
Correspondent
Navigant Consulting, Inc.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact ALLISON SCOTT
Regulation Number878.4780
Classification Product Code
OMP  
Date Received10/20/2014
Decision Date 04/20/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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