FDA 510(k) Application Details - K133242

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K133242
Device Name	Unit, Phacofragmentation
Applicant	BAUSCH & LOMB 3365 TREE COURT INDUSTRIAL BLV ST LOUIS, MO 63122 US Other 510(k) Applications for this Company
Contact	TIMOTHY W CAPEHART Other 510(k) Applications for this Contact
Regulation Number	886.4670   More FDA Info for this Regulation Number
Classification Product Code	HQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2013
Decision Date	02/14/2014
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