FDA 510(k) Application Details - K111169

Device Classification Name	Headgear, Extraoral, Orthodontic   More FDA Info for this Device
510(K) Number	K111169
Device Name	Headgear, Extraoral, Orthodontic
Applicant	KWANG MYUNG DAICOM INC 951 STARBUCK ST. UNIT J FULLERTON, CA 92833 US Other 510(k) Applications for this Company
Contact	Priscilla Chung 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	04/26/2011
Decision Date	10/03/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review