FDA 510(k) Application Details - K961754

Device Classification Name	Headgear, Extraoral, Orthodontic   More FDA Info for this Device
510(K) Number	K961754
Device Name	Headgear, Extraoral, Orthodontic
Applicant	G & H WIRE CO. 1791 INDUSTRIAL DR. GREENWOOD, IN 46142 US Other 510(k) Applications for this Company
Contact	MICHAEL JAHNS 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	05/06/1996
Decision Date	07/10/1996
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