FDA 510(k) Application Details - K003512

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K003512
Device Name	Unit, Phacofragmentation
Applicant	A.R.C. LASER AG 2417 SOUTH 3850 WEST SALT LAKE CITY, UT 84120 US Other 510(k) Applications for this Company
Contact	DANIEL HOEFER 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	11/14/2000
Decision Date	02/08/2001
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