FDA 510(k) Application Details - K212198

Device Classification Name	Wrap, Sterilization   More FDA Info for this Device
510(K) Number	K212198
Device Name	Wrap, Sterilization
Applicant	Plasmapp Co,.Ltd. BVC-111, 125, Gwahak-ro, Yuseong-gu Daejeon 34141 KR Other 510(k) Applications for this Company
Contact	Lee Seung Hun Other 510(k) Applications for this Contact
Regulation Number	880.6850   More FDA Info for this Regulation Number
Classification Product Code	FRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2021
Decision Date	10/22/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review