FDA 510(k) Application Details - K052553

Device Classification Name	Headgear, Extraoral, Orthodontic   More FDA Info for this Device
510(K) Number	K052553
Device Name	Headgear, Extraoral, Orthodontic
Applicant	RUSSELL SAMUELS ORTHODONTIC DESIGN 7 CRICKET LANE LOUGHBOROUGH, LEICESTERSHIRE, ENGLAND LE11 3PD GB Other 510(k) Applications for this Company
Contact	RUSSELL HENRY ASHLEIGH SAMUELS 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	09/16/2005
Decision Date	12/22/2005
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