Cardinal Health NPWT PRO, Cardinal Health NPWT PRO To Go, Cardinal Health NPWT PRO At Home

Negative Pressure Wound Therapy Powered Suction Pump

CARDINAL HEALTH

The following data is part of a premarket notification filed by Cardinal Health with the FDA for Cardinal Health Npwt Pro, Cardinal Health Npwt Pro To Go, Cardinal Health Npwt Pro At Home.

Pre-market Notification Details

Device IDK143016
510k NumberK143016
Device Name:Cardinal Health NPWT PRO, Cardinal Health NPWT PRO To Go, Cardinal Health NPWT PRO At Home
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant CARDINAL HEALTH 1500 S Waukegan Rd Waukegan,  IL  60085
ContactTatyana Bogdan
CorrespondentAllison Scott
NAVIGANT CONSULTING, INC. 9001 WESLEYAN ROAD, SUITE 200 Indianapolis,  IN  46268
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-20
Decision Date2015-04-20
Summary:summary

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