FDA 510(k) Application Details - K980151

Device Classification Name	Headgear, Extraoral, Orthodontic   More FDA Info for this Device
510(K) Number	K980151
Device Name	Headgear, Extraoral, Orthodontic
Applicant	ORTHO KINETICS CORP. 1611A SOUTH MELROSE DRIVE, SUITE 16 VISTA, CA 92083 US Other 510(k) Applications for this Company
Contact	STEVEN O LUSE 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	01/16/1998
Decision Date	04/06/1998
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