FDA 510(k) Application Details - K982599

Device Classification Name	Sponge, Ophthalmic   More FDA Info for this Device
510(K) Number	K982599
Device Name	Sponge, Ophthalmic
Applicant	OPHTHALMIC SOLUTIONS, LLC. 2179 NORTHLAKE PKWY., BLDG. 5 SUITE 115 TUCKER, GA 30084 US Other 510(k) Applications for this Company
Contact	DARIA A FREMSTAD 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	07/27/1998
Decision Date	02/16/1999
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