FDA 510(k) Application Details - K011191

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K011191
Device Name	Sponge, Ophthalmic
Applicant	MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH JACKSONVILLE, FL 32216 US Other 510(k) Applications for this Company
Contact	DIANA TAYLOR Other 510(k) Applications for this Contact
Regulation Number	886.4790   More FDA Info for this Regulation Number
Classification Product Code	HOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2001
Decision Date	06/26/2001
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