FDA 510(k) Application Details - K202929

Device Classification Name	More FDA Info for this Device
510(K) Number	K202929
Device Name	Nexpowder
Applicant	Nextbiomedical Co., Ltd. 6 Venture-ro 100 beon-gil, Yeonsu-gu Incheon 22013 KR Other 510(k) Applications for this Company
Contact	Jin Young Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2020
Decision Date	09/16/2022
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