FDA 510(k) Application Details - K203282

Device Classification Name	Plate, Bone   More FDA Info for this Device
510(K) Number	K203282
Device Name	Plate, Bone
Applicant	Industrias Medicas Sampedro S.A.S. Carrera 47 N 100 Sur 40 Centro Industrial Portal del Sur Bodega 14 La Estrella 055468 CO Other 510(k) Applications for this Company
Contact	Leidy Johanna Toro Gonzalez 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	11/06/2020
Decision Date	05/19/2021
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