FDA 510(k) Application Details - K031548

Device Classification Name	Light, Headband, Surgical   More FDA Info for this Device
510(K) Number	K031548
Device Name	Light, Headband, Surgical
Applicant	WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 SKANEATELES FALLS, NY 13153-0220 US Other 510(k) Applications for this Company
Contact	DAVID KLEMENTOWSKI Other 510(k) Applications for this Contact
Regulation Number	886.4335   More FDA Info for this Regulation Number
Classification Product Code	FSR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2003
Decision Date	08/11/2003
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