FDA 510(k) Application Details - K993361

Device Classification Name	Tubing, Replacement, Phacofragmentation Unit   More FDA Info for this Device
510(K) Number	K993361
Device Name	Tubing, Replacement, Phacofragmentation Unit
Applicant	HURRICANE MEDICAL 2331K 63RD AVE. EAST BRADENTON, FL 34203 US Other 510(k) Applications for this Company
Contact	DAVID A CLAPP 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	10/06/1999
Decision Date	01/04/2000
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