FDA 510(k) Application Details - K000358

Device Classification Name	Headgear, Extraoral, Orthodontic   More FDA Info for this Device
510(K) Number	K000358
Device Name	Headgear, Extraoral, Orthodontic
Applicant	ORTHO TECHNOLOGY 8909 REGENTS PARB DR., #410 TAMPA, FL 33647 US Other 510(k) Applications for this Company
Contact	BRIAN LEAGHTY 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	02/04/2000
Decision Date	06/09/2000
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