FDA 510(k) Application Details - K970268

Device Classification Name	Ophthalmoscopes,Replacement Batteries,Hand-Held   More FDA Info for this Device
510(K) Number	K970268
Device Name	Ophthalmoscopes,Replacement Batteries,Hand-Held
Applicant	ALEXANDER MFG. CO. 1511 S GARFIELD PL MASON CITY, IA 50401 US Other 510(k) Applications for this Company
Contact	STACEY HIPPEN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MSG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/1997
Decision Date	03/31/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review