FDA 510(k) Application Details - K233658

Device Classification Name	Tube, Tympanostomy   More FDA Info for this Device
510(K) Number	K233658
Device Name	Tube, Tympanostomy
Applicant	Biowy Corporation 27031 Vista Terrace Lake Forest, CA 92630 US Other 510(k) Applications for this Company
Contact	Zhihua Lu Other 510(k) Applications for this Contact
Regulation Number	874.3880   More FDA Info for this Regulation Number
Classification Product Code	ETD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2023
Decision Date	02/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review