FDA 510(k) Application Details - K232889

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K232889
Device Name	Plate, Bone
Applicant	Meticuly Co., Ltd. 924 B bldg., Rm. B116-118, B210-212 Soi Chula 7, Wang Mai, Pathum Wan Bangkok 10330 TH Other 510(k) Applications for this Company
Contact	Peeranoot Lohwongwatana Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	JEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2023
Decision Date	04/30/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review