FDA 510(k) Application Details - K162543

Device Classification Name	Headgear, Extraoral, Orthodontic   More FDA Info for this Device
510(K) Number	K162543
Device Name	Headgear, Extraoral, Orthodontic
Applicant	SAWBROS INDUSTRIES PVT.LTD. A-68 SECTOR 2 NOIDA 201301 IN Other 510(k) Applications for this Company
Contact	DHRUV SAWHNEY Other 510(k) Applications for this Contact
Regulation Number	872.5500   More FDA Info for this Regulation Number
Classification Product Code	DZB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2016
Decision Date	08/28/2017
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