FDA 510(k) Application Details - K002031

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K002031
Device Name	Unit, Phacofragmentation
Applicant	ASCLEPION-MEDITEC AG 2525 MC GAW AVE. IRVINE, CA 92623-9791 US Other 510(k) Applications for this Company
Contact	WILLIAM KELLEY 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	07/03/2000
Decision Date	12/27/2000
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