FDA 510(k) Application Details - K213853

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K213853
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	Smith and Nephew Medical Limited 101 Hessle Road Hull HU3 2BN GB Other 510(k) Applications for this Company
Contact	Jean-Marie Steeve Other 510(k) Applications for this Contact
Regulation Number	878.4780   More FDA Info for this Regulation Number
Classification Product Code	OMP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2021
Decision Date	02/10/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review