FDA 510(k) Application Details - K974313

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K974313
Device Name	Sponge, Ophthalmic
Applicant	HYDROFERA, LLC. 322 MAIN ST., SUITE 1101 WILLIMANTIC, CT 06226 US Other 510(k) Applications for this Company
Contact	HEATHER S BOND 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	11/17/1997
Decision Date	03/02/1998
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