FDA 510(k) Application Details - K212200

Device Classification Name	Sterilizer, Chemical   More FDA Info for this Device
510(K) Number	K212200
Device Name	Sterilizer, Chemical
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	880.6860   More FDA Info for this Regulation Number
Classification Product Code	MLR 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