FDA 510(k) Application Details - K040204

Device Classification Name	Keratome, Ac-Powered   More FDA Info for this Device
510(K) Number	K040204
Device Name	Keratome, Ac-Powered
Applicant	BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 US Other 510(k) Applications for this Company
Contact	DEBRA L.B. KETCHUM Other 510(k) Applications for this Contact
Regulation Number	886.4370   More FDA Info for this Regulation Number
Classification Product Code	HNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2004
Decision Date	03/22/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review