FDA 510(k) Application Details - K132796

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K132796
Device Name	Sponge, Ophthalmic
Applicant	HUIZHOU FORYOU MEDICAL DEVICES CO, LTD P.O. BOX 120-119 SHANGHAI 200120 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	09/06/2013
Decision Date	10/30/2013
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