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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 K150124
Device Name Cardinal Health NPWT PRO HC
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 Received01/20/2015
Decision Date 09/02/2015
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
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