FDA 510(k) Application Details - K961524

Device Classification Name	Cystotome   More FDA Info for this Device
510(K) Number	K961524
Device Name	Cystotome
Applicant	STERILAB, INC. 6068 CORTE DEL CEDRO CARLSBAD, CA 92009 US Other 510(k) Applications for this Company
Contact	JONATHAN WOODWARD Other 510(k) Applications for this Contact
Regulation Number	886.4350   More FDA Info for this Regulation Number
Classification Product Code	HNY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/1996
Decision Date	05/16/1996
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