FDA 510(k) Application Details - K141638

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K141638
Device Name	Ophthalmoscope, Ac-Powered
Applicant	PROPPER MANUFACTURING CO.,INC. 36-04 SKILLMAN AVENUE LONG ISLAND CITY, NY 11101 US Other 510(k) Applications for this Company
Contact	ANDREW SHARAVARA Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	HLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2014
Decision Date	09/17/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review