FDA 510(k) Application Details - K994340

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K994340
Device Name	Ophthalmoscope, Ac-Powered
Applicant	HAI LABORATORIES, INC. 30 NORTHPOINT RD. SOUND BEACH, NY 11789-1734 US Other 510(k) Applications for this Company
Contact	RICHARD C LANZILLOTTO 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	12/23/1999
Decision Date	09/20/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review