FDA 510(k) Application Details - K211571

Device Classification Name	Negative Pressure Wound Therapy Powered Suction Pump   More FDA Info for this Device
510(K) Number	K211571
Device Name	Negative Pressure Wound Therapy Powered Suction Pump
Applicant	Zhejiang Longterm Medical Technology Co., LTD No. 493 North Huancheng Road Mogan Mountain National High-Tech District Deqing 313200 CN Other 510(k) Applications for this Company
Contact	Claudia Zsang 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	05/21/2021
Decision Date	05/31/2022
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