IVALON OPHTHALMIC SPONGE

Sponge, Ophthalmic

IVALON

The following data is part of a premarket notification filed by Ivalon with the FDA for Ivalon Ophthalmic Sponge.

Pre-market Notification Details

Device IDK946016
510k NumberK946016
Device Name:IVALON OPHTHALMIC SPONGE
ClassificationSponge, Ophthalmic
Applicant IVALON 5374 LINDA VISTA RD., SUITE C San Diego,  CA  92110
ContactElizabeth J Melaragno
CorrespondentElizabeth J Melaragno
IVALON 5374 LINDA VISTA RD., SUITE C San Diego,  CA  92110
Product CodeHOZ  
CFR Regulation Number886.4790 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-09
Decision Date1995-03-22

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