FDA 510(k) Application Details - K972522

Device Classification Name	Tubing, Replacement, Phacofragmentation Unit   More FDA Info for this Device
510(K) Number	K972522
Device Name	Tubing, Replacement, Phacofragmentation Unit
Applicant	MED-LOGICS, INC. 27071 CABOT ROAD, SUITE 127 LAGUNA HILLS, CA 92653 US Other 510(k) Applications for this Company
Contact	GLENN A DUNKI-JACOBS Other 510(k) Applications for this Contact
Regulation Number	886.4150   More FDA Info for this Regulation Number
Classification Product Code	MSR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/1997
Decision Date	09/30/1997
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