FDA 510(k) Application Details - K003638

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K003638
Device Name	Unit, Phacofragmentation
Applicant	ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 IRVINE, CA 92623-9534 US Other 510(k) Applications for this Company
Contact	MARK O'DONNELL 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	11/24/2000
Decision Date	02/13/2001
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