FDA 510(k) Application Details - K971795

Device Classification Name	Unit, Phacofragmentation   More FDA Info for this Device
510(K) Number	K971795
Device Name	Unit, Phacofragmentation
Applicant	PARADIGM MEDICAL INDUSTRIES, INC. 1772 WEST 2300 SOUTH SALT LAKE CITY, UT 84119 US Other 510(k) Applications for this Company
Contact	RICHARD DIRKSON 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	05/15/1997
Decision Date	07/14/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review