FDA 510(k) Application Details - K993224

Device Classification Name	Headgear, Extraoral, Orthodontic   More FDA Info for this Device
510(K) Number	K993224
Device Name	Headgear, Extraoral, Orthodontic
Applicant	DONTECH PRODUCTS B.V. AVELINGENWEST 27C GORINCHEM, ZH NL Other 510(k) Applications for this Company
Contact	JAN JORENS 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	09/27/1999
Decision Date	02/11/2000
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