FDA 510(k) Application Details - K974469

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K974469
Device Name	Unit, Phacofragmentation
Applicant	MENTOR CORP. 5425 HOLLISTER AVE. SANTA BARBARA, CA 93111 US Other 510(k) Applications for this Company
Contact	DONNA A CRAWFORD 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	11/26/1997
Decision Date	02/24/1998
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