FDA 510(k) Application Details - K241229

Device Classification Name	Plug, Punctum   More FDA Info for this Device
510(K) Number	K241229
Device Name	Plug, Punctum
Applicant	Bio Optics Co., Ltd. A-1215, SKV1 Tower, 14, Galmachi-ro 288beon-gil, Jungwon-gu Seongnam-si 13201 KR Other 510(k) Applications for this Company
Contact	SangHoon Jung Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LZU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2024
Decision Date	06/28/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review