FDA 510(k) Application Details - K011199

Device Classification Name	Tonometer, Manual   More FDA Info for this Device
510(K) Number	K011199
Device Name	Tonometer, Manual
Applicant	BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 US Other 510(k) Applications for this Company
Contact	DOUGLAS J FORTUNATO Other 510(k) Applications for this Contact
Regulation Number	886.1930   More FDA Info for this Regulation Number
Classification Product Code	HKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2001
Decision Date	07/02/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review