Kendall NPWT Incision Management Device

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 Kendall Npwt Incision Management Device.

Pre-market Notification Details

Device IDK202217
510k NumberK202217
Device Name:Kendall NPWT Incision Management Device
ClassificationNegative Pressure Wound Therapy Powered Suction Pump
Applicant Cardinal Health 3651 Birchwood Drive Waukegan,  IL  60085
ContactChristine Kuntz-nassif
CorrespondentJillian Connery
Patient Recovery, Cardinal Health 777 West Street Mansfield,  MA  02048
Product CodeOMP  
CFR Regulation Number878.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-06
Decision Date2021-06-04

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