FDA 510(k) Application Details - K012196

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K012196
Device Name	Sponge, Ophthalmic
Applicant	ULTRACELL MEDICAL TECHNOLOGIES, INC. 183 PROVIDENCE, NEW LONDON TNPK NORTH STONINGTON, CT 06359 US Other 510(k) Applications for this Company
Contact	COLLEEN MARTIN 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	07/13/2001
Decision Date	08/24/2001
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