FDA 510(k) Application Details - K192970

Device Classification Name	More FDA Info for this Device
510(K) Number	K192970
Device Name	SLIMUS
Applicant	HIRONIC Co., Ltd 19F, 767, Sinsu-Ro, Suji-Gu Yongin-Si 16827 KR Other 510(k) Applications for this Company
Contact	Duk Ho Kong Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2019
Decision Date	12/01/2020
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