FDA 510(k) Application Details - K093006

Device Classification Name	Calibrator, Hearing Aid / Earphone And Analysis Systems   More FDA Info for this Device
510(K) Number	K093006
Device Name	Calibrator, Hearing Aid / Earphone And Analysis Systems
Applicant	FRYE ELECTRONICS, INC. 9826 S.W. TIGARD ST. TIGARD, OR 97223 US Other 510(k) Applications for this Company
Contact	KRISTINA FRYE Other 510(k) Applications for this Contact
Regulation Number	874.3310   More FDA Info for this Regulation Number
Classification Product Code	ETW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2009
Decision Date	12/30/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review