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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 K161418
Device Name Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
Applicant
Cardinalhealth
1500 S Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact Judith Harbour
Correspondent
Cardinalhealth
1500 S Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact Tatyana Bogdan-Curvin
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/23/2016
Decision Date 01/19/2017
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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