FDA 510(k) Application Details - K071970

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K071970
Device Name	Aligner, Sequential
Applicant	SPECIALTY APPLIANCE WORKS, INC. 2193 SPEAR POINT DR. MARIETTA, GA 30062 US Other 510(k) Applications for this Company
Contact	JAMES W KOLKA Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NXC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2007
Decision Date	09/25/2007
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