FDA 510(k) Application Details - K980100

Device Classification Name	Tubing, Replacement, Phacofragmentation Unit   More FDA Info for this Device
510(K) Number	K980100
Device Name	Tubing, Replacement, Phacofragmentation Unit
Applicant	STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. ST. LOUIS, MO 63122-6694 US Other 510(k) Applications for this Company
Contact	PATRICK G BALSMANN 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	01/12/1998
Decision Date	06/01/1998
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