FDA 510(k) Application Details - K001125

Device Classification Name	Injector, Capsular Tension Ring   More FDA Info for this Device
510(K) Number	K001125
Device Name	Injector, Capsular Tension Ring
Applicant	GEUDER GMBH 344 ANNABELLE POINT RD. CENTERVILLE, MA 02632-2402 US Other 510(k) Applications for this Company
Contact	HILLARD W WELCH 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	04/07/2000
Decision Date	10/04/2000
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