FDA 510(k) Application Details - K011498

Device Classification Name	Injector, Capsular Tension Ring   More FDA Info for this Device
510(K) Number	K011498
Device Name	Injector, Capsular Tension Ring
Applicant	OPHTEC USA, INC. 6421 CONGRESS AVE., SUITE 112 BOCA RATON, FL 33487 US Other 510(k) Applications for this Company
Contact	RICK MCCARLEY Other 510(k) Applications for this Contact
Regulation Number	886.4300   More FDA Info for this Regulation Number
Classification Product Code	NCE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2001
Decision Date	07/09/2001
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